Non-invasive interactive neurostimulation (InterX ™) reduces acute pain in patients following total knee replacement surgery: a randomised, controlled trial
Background Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potentia...
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| Published in | Journal of orthopaedic surgery and research Vol. 6; no. 1; p. 45 |
|---|---|
| Main Authors | , , |
| Format | Journal Article |
| Language | English |
| Published |
London
BioMed Central
24.08.2011
BioMed Central Ltd BMC |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1749-799X 1749-799X |
| DOI | 10.1186/1749-799X-6-45 |
Cover
| Abstract | Background
Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome
.
Methods
A clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures.
Results
Sixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis.
The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not achieve this ROM.
Conclusions
The results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group. |
|---|---|
| AbstractList | Background Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome. Methods A clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures. Results Sixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis. The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not achieve this ROM. Conclusions The results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group. Abstract Background: Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome . Methods: A clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures. Results: Sixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis. The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not achieve this ROM. Conclusions: The results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group. Background Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome . Methods A clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures. Results Sixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis. The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not achieve this ROM. Conclusions The results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group. Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome. A clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures. Sixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis. The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not achieve this ROM. The results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group. Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome. A clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures. Sixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis. The results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group. Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome.BACKGROUNDAdequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome.A clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures.METHODSA clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures.Sixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis. The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not achieve this ROM.RESULTSSixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis. The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not achieve this ROM.The results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group.CONCLUSIONSThe results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group. |
| ArticleNumber | 45 |
| Audience | Academic |
| Author | Nigam, Ashok K Taylor, Drena M Valeyeva, Zulia |
| AuthorAffiliation | 1 Prince Philip Hospital, Carmarthenshire NHS Trust, Mawr Dafen, Llanelli, UK 2 InterX Clinic Cheltenham, Maple House, Bayshill Rd, Cheltenham, Glouc, UK |
| AuthorAffiliation_xml | – name: 2 InterX Clinic Cheltenham, Maple House, Bayshill Rd, Cheltenham, Glouc, UK – name: 1 Prince Philip Hospital, Carmarthenshire NHS Trust, Mawr Dafen, Llanelli, UK |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/21864362$$D View this record in MEDLINE/PubMed |
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| Copyright | Nigam et al; licensee BioMed Central Ltd. 2011 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. COPYRIGHT 2011 BioMed Central Ltd. 2011 Nigam et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyright ©2011 Nigam et al; licensee BioMed Central Ltd. 2011 Nigam et al; licensee BioMed Central Ltd. |
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| Keywords | Patient Control Analgesia Total Knee Replacement Total Knee Replacement Patient Verbal Rate Scale Transcutaneous Electrical Nerve Stimulation |
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| Snippet | Background
Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation... Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and... Background Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation... Abstract Background: Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster... Abstract Background Adequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster... |
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| SubjectTerms | Acute pain Aged Analgesics - therapeutic use Arthroplasty, Replacement, Knee - adverse effects Care and treatment Combined Modality Therapy Diagnosis Electric Stimulation Therapy - instrumentation Electric Stimulation Therapy - methods Female Humans Knee Joint - physiology Knee Joint - surgery Male Medicine Medicine & Public Health Orthopedics Pain, Postoperative - etiology Pain, Postoperative - therapy Prospective Studies Range of Motion, Articular - physiology Research Article Surgical Orthopedics Treatment Outcome |
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| Title | Non-invasive interactive neurostimulation (InterX ™) reduces acute pain in patients following total knee replacement surgery: a randomised, controlled trial |
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