NCT07233343

Brief Summary

The aim of this study, designed as a randomized controlled trial, is to investigate the effects of fascial mobilization treatment on pain, grip strength, and manual dexterity in patients with postpartum carpal tunnel syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 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

Study Start

First participant enrolled

August 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

Carpal Tunnel Syndrome (CTS)fascial mobilizationgrip strengthHand Skillspain

Outcome Measures

Primary Outcomes (5)

  • The Pain

    Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

    through of the study, average 12 weeks

  • Pain pressure threshold

    After localizing the painful area by palpation, force will be applied with an algometer until the patient experiences pain and discomfort. The value displayed on the algometer will be recorded, and three measurements will be taken, and the average will be used for analysis. PPT measurement with an algometer is a reliable method for determining tissue nociceptive sensitivity.

    through of the study, average 12 weeks

  • Grip strength

    A Jamar hand dynamometer will be used to measure patients' grip strength. Grip strength is measured with the Jamar hand dynamometer, recommended by the American Association of Hand Therapists (AETD) and whose validity and reliability have been confirmed in numerous studies. This device is considered the gold standard for measuring hand grip strength. Measurements will be taken before and after treatment, and three times, 10 seconds apart. Each measurement will be taken at the same difficulty level. Generally, the average of the three measurements will be taken.

    through of the study, average 12 weeks

  • Hand skills

    The Moberg test has functional value because it reflects manual performance. It relies heavily on motor control of the thumb, index finger, and middle finger. The test is administered in two stages: with eyes open and eyes closed, beginning with the dominant hand. A box, 12 small metal objects (screws, paper clips, key ring, safety pin, small nuts, coins, and a key), and a stopwatch are used to administer the test. Subjects are instructed to pick up each object one by one and place it in the box as quickly as possible without slipping. The time from the initial position until the last object is released is recorded. The test is then repeated with eyes closed. The test is repeated three times, with the best result recorded.

    through of the study, average 12 weeks

  • Hand skills

    The Nine-Hole Peg test, used to assess manual dexterity, involves patients quickly removing nine wooden pegs from a storage box, placing them in random holes, then collecting them from the holes and returning them to the storage compartment. The time is measured in seconds using a stopwatch, and anything over 20 seconds is considered a "loss of skill."

    through of the study, average 12 weeks

Secondary Outcomes (4)

  • Upper extremity functionality

    through of the study, average 12 weeks

  • Carpal tunnel symptom severity

    through of the study, average 12 weeks

  • Wrist edema evaluation

    through of the study, average 3 weeks

  • Anxiety

    through of the study, average 12 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

This group will get conventional physiotherapy that is include range of motion exercises, electrotherapy and resistance exercise training.

Other: Conventional physiotherapy

Fascial mobilization group

EXPERIMENTAL

This group will get a specific programme that combinated with conventional physiotherapy and fascial mobilization therapy

Other: Fascial mobilization therapy

Interventions

Conservative treatment methods such as TENS, normal joint range of motion exercises, tendon gliding exercises and nerve mobilizations will be applied twice a week for 12 weeks, with each session lasting 45 minutes.

Control group

In addition to conservative treatment methods, the patients in the study group will receive fascial mobilization techniques, including the flexor retinacula technique, the lacertus fibrosus technique, and 90-120 seconds of application to the epimysial fascia of the wrist flexor muscles. The patients in the study group will receive the same treatment, twice a week for 12 weeks, with each session lasting 45 minutes.

Fascial mobilization group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince the study was conducted on patients diagnosed with carpal tunnel in the post-partum period, only female patients were included in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having been diagnosed with CTS by a physician
  • Being in the post-pregnancy period (first year)
  • Presence of pregnancy-related edema
  • Presence of pain, tenderness, and numbness in the median nerve neurodynamic test
  • Positive Tinnel and Phalen tests
  • Individuals who volunteered to participate in the study

You may not qualify if:

  • Having a history of CTS before pregnancy
  • Being diagnosed with a cervical disc herniation
  • Individuals with a history of upper extremity surgery within the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Gaziantep, (505) 090-5846, Turkey (Türkiye)

Location

Related Publications (10)

  • Branchini M, Lopopolo F, Andreoli E, Loreti I, Marchand AM, Stecco A. Fascial Manipulation(R) for chronic aspecific low back pain: a single blinded randomized controlled trial. F1000Res. 2015 Nov 3;4:1208. doi: 10.12688/f1000research.6890.2. eCollection 2015.

  • Karjalanen T, Raatikainen S, Jaatinen K, Lusa V. Update on Efficacy of Conservative Treatments for Carpal Tunnel Syndrome. J Clin Med. 2022 Feb 11;11(4):950. doi: 10.3390/jcm11040950.

  • Abdolrazaghi HA, Khansari M, Mirshahi M, Ahmadi Pishkuhi M. Effectiveness of Tendon and Nerve Gliding Exercises in the Treatment of Patients With Mild Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial. Hand (N Y). 2023 Mar;18(2):222-229. doi: 10.1177/15589447211006857. Epub 2021 Apr 15.

  • Huisstede BM, Friden J, Coert JH, Hoogvliet P; European HANDGUIDE Group. Carpal tunnel syndrome: hand surgeons, hand therapists, and physical medicine and rehabilitation physicians agree on a multidisciplinary treatment guideline-results from the European HANDGUIDE Study. Arch Phys Med Rehabil. 2014 Dec;95(12):2253-63. doi: 10.1016/j.apmr.2014.06.022. Epub 2014 Aug 12.

  • Kozak A, Schedlbauer G, Wirth T, Euler U, Westermann C, Nienhaus A. Association between work-related biomechanical risk factors and the occurrence of carpal tunnel syndrome: an overview of systematic reviews and a meta-analysis of current research. BMC Musculoskelet Disord. 2015 Sep 1;16:231. doi: 10.1186/s12891-015-0685-0.

  • Heebner ML, Roddey TS. The effects of neural mobilization in addition to standard care in persons with carpal tunnel syndrome from a community hospital. J Hand Ther. 2008 Jul-Sep;21(3):229-40; quiz 241. doi: 10.1197/j.jht.2007.12.001.

  • Ng CL, Ho DD, Chow SP. The Moberg pickup test: results of testing with a standard protocol. J Hand Ther. 1999 Oct-Dec;12(4):309-12. doi: 10.1016/s0894-1130(99)80069-6.

  • Oxford Grice K, Vogel KA, Le V, Mitchell A, Muniz S, Vollmer MA. Adult norms for a commercially available Nine Hole Peg Test for finger dexterity. Am J Occup Ther. 2003 Sep-Oct;57(5):570-3. doi: 10.5014/ajot.57.5.570.

  • Yakut Y, Yakut E, Bayar K, Uygur F. Reliability and validity of the Turkish version short-form McGill pain questionnaire in patients with rheumatoid arthritis. Clin Rheumatol. 2007 Jul;26(7):1083-7. doi: 10.1007/s10067-006-0452-6. Epub 2006 Nov 15.

  • Sheereen FJ, Sarkar B, Sahay P, Shaphe MA, Alghadir AH, Iqbal A, Ali T, Ahmad F. Comparison of Two Manual Therapy Programs, including Tendon Gliding Exercises as a Common Adjunct, While Managing the Participants with Chronic Carpal Tunnel Syndrome. Pain Res Manag. 2022 Jun 8;2022:1975803. doi: 10.1155/2022/1975803. eCollection 2022.

MeSH Terms

Conditions

Carpal Tunnel SyndromePain

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tuğba GÖNEN, Asisst. Prof. Dr.

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were divided in two groups. One group will get intervention. One group will be the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisst. Prof. Dr.

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

August 10, 2024

Primary Completion

November 10, 2024

Study Completion

June 10, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations