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| Name | Class |
|---|---|
| Hospital Universitario Fundación Alcorcón | OTHER |
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It is a randomized clinical trial comparing surgical and conservative (physical therapy) treatments for women with carpal tunnel syndrome (CTS). The purpose of the study is to determine the efficacy of physical therapy versus endoscopic surgery in pain and disability in women with carpal tunnel syndrome at medium and long-term follow-up periods. We hypothesized that proper physical therapy approach can be equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.
Scientific evidence for the management of CTS has exhibited conflicting results. The Cochrane review concluded that surgical treatment relieves symptoms significantly better than splinting but further research is needed. A systematic review focused on physical therapy for the management of CTS included 6 studies and found weak to strong effect of neural gliding exercises. Recent studies have revealed complex nociceptive mechanisms involved in CTS which should be carefully considered during the management of these patients. Proper physical therapy interventions can modulate nociceptive processes found in CTS. We will perform a randomized clinical trial nested within a prospective cohort as our study design to determine if proper physical therapy approach targeted to modulate sensitization processes is equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative group | Experimental | The conservative group will received 3 treatment sessions of physical therapy based on neuromodulation of nociceptive processing of 30 minutes of duration, once per week. |
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| Surgical group | Active Comparator | The surgical group will receive the surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative group | Other | The conservative group will received 3 treatment sessions of physical therapy based on neuromodulation of nociceptive processing of 30 minutes of duration, once per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the intensity of pain symptoms between baseline and follow-up periods | A 10-cm Numerical Pain Rating Scale(NPRS; 0: no pain, 10: maximum pain) will be used to assess current level of hand pain, and worst level of hand pain experienced in the preceding week. | Baseline and 1, 3, 6 and 12 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in patients self-perceived improvement between baseline and follow-up periods | Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better). Descriptors of worsening or improving are assigned with values ranging from -1 to -7 and +1 to +7, respectively. | Baseline and 1, 3, 6 and 12 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Health-related quality of life (economic analysis) | The paper-based five-level version of EuroQol-5D (EQ-5D-5L) was used. | Baseline, and 1, 3, 6 and 12 months after the intervention |
| Changes in the intensity of pain symptoms between baseline and 4 years follow-up (extended follow-up) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| César Fernández-de-las-Peñas, PT, PhD, DMSc | Universidad Rey Juan Carlos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Rey Juan Carlos - Hospital Universitario Fundación Alcorcon | Alcorcón | Madrid | 28922 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37582474 | Derived | Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Cleland JA, Cook C, de-la-Llave-Rincon AI, Valera-Calero JA, Plaza-Manzano G. Minimal Clinically Important Differences in Hand Pain Intensity (Numerical Pain Rate Scale) and Related-Function (Boston Carpal Tunnel Questionnaire) in Women With Carpal Tunnel Syndrome. Arch Phys Med Rehabil. 2024 Jan;105(1):67-74. doi: 10.1016/j.apmr.2023.07.018. Epub 2023 Aug 13. | |
| 35194646 |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D020423 | Median Neuropathy |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| Surgical group | Procedure | The surgical group will receive the surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols. |
|
| Changes in function between baseline and follow-up periods | The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5 point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity. | Baseline, and 1, 3, 6 and 12 months after intervention |
| Changes in severity of the symptoms between baseline and follow-up periods | The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5 point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity. | Baseline, and 1, 3, 6 and 12 months after the intervention |
A 10-cm Numerical Pain Rating Scale(NPRS; 0: no pain, 10: maximum pain) will be used to assess current level of hand pain, and worst level of hand pain experienced in the preceding week. |
| Baseline and 48 months after the intervention (extended follow-up) |
| Changes in function and severity of symptoms between baseline and 4 years follow-up (extended follow-up) | The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5 point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity. | Baseline and 48 months after the intervention (extended follow-up) |
| Derived |
| Liew BXW, de-la-Llave-Rincon AI, Scutari M, Arias-Buria JL, Cook CE, Cleland J, Fernandez-de-Las-Penas C. Do Short-Term Effects Predict Long-Term Improvements in Women Who Receive Manual Therapy or Surgery for Carpal Tunnel Syndrome? A Bayesian Network Analysis of a Randomized Clinical Trial. Phys Ther. 2022 Apr 1;102(4):pzac015. doi: 10.1093/ptj/pzac015. |
| 32766779 | Derived | Fernandez-de-Las-Penas C, Arias-Buria JL, Cleland JA, Pareja JA, Plaza-Manzano G, Ortega-Santiago R. Manual Therapy Versus Surgery for Carpal Tunnel Syndrome: 4-Year Follow-Up From a Randomized Controlled Trial. Phys Ther. 2020 Oct 30;100(11):1987-1996. doi: 10.1093/ptj/pzaa150. |
| 26281946 | Derived | Fernandez-de-Las Penas C, Ortega-Santiago R, de la Llave-Rincon AI, Martinez-Perez A, Fahandezh-Saddi Diaz H, Martinez-Martin J, Pareja JA, Cuadrado-Perez ML. Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial. J Pain. 2015 Nov;16(11):1087-94. doi: 10.1016/j.jpain.2015.07.012. Epub 2015 Aug 15. |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |