NCT01789645

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

February 20, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2019

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

February 6, 2013

Last Update Submit

August 14, 2019

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnelPhysical therapySurgeryEfficacy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Changes in patients self-perceived improvement between baseline and follow-up periods

    Baseline and 1, 3, 6 and 12 months after the intervention

  • Changes in function between baseline and follow-up periods

    Baseline, and 1, 3, 6 and 12 months after intervention

  • Changes in severity of the symptoms between baseline and follow-up periods

    Baseline, and 1, 3, 6 and 12 months after the intervention

Other Outcomes (3)

  • Changes in Health-related quality of life (economic analysis)

    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)

    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)

    Baseline and 48 months after the intervention (extended follow-up)

Study Arms (2)

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.

Other: Conservative group

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.

Procedure: Surgical group

Interventions

Conservative groupOTHER

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.

Conservative group
Surgical groupPROCEDURE

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.

Surgical group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pain and paresthesia in the median nerve distribution without extra-median nerve territory symptoms;
  • increasing symptoms during night;
  • Tinel sign;
  • Phalen sign;
  • self-reported hand strength deficits.
  • Deficits of sensory and motor nerve conduction of the median nerve according to standardized guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation

You may not qualify if:

  • if any sensory/motor deficit in ulnar or radial nerve was present;
  • previous interventions with surgery or steroid injections;
  • multiple diagnoses of the upper extremity (i.e., cervical radiculopathy, lateral epicondylalgia);
  • history of neck, shoulder or arm trauma;
  • history of a systemic disease causing CTS (e.g. diabetes mellitus, or thyroid disease);
  • history of systemic musculoskeletal conditions (e.g. rheumatoid arthritis, fibromyalgia);
  • if the patient was actively involved with or seeking litigation at the time of the study;
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos - Hospital Universitario Fundación Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (4)

  • 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.

    PMID: 37582474DERIVED

  • 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.

    PMID: 35194646DERIVED

  • 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.

    PMID: 32766779DERIVED

  • 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.

    PMID: 26281946DERIVED

MeSH Terms

Conditions

Carpal Tunnel SyndromeMedian Neuropathy

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • César Fernández-de-las-Peñas, PT, PhD, DMSc

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 12, 2013

Study Start

February 20, 2013

Primary Completion

January 25, 2014

Study Completion

January 28, 2019

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations

ES(1)