NCT05475808

Brief Summary

It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

July 25, 2022

Last Update Submit

February 25, 2025

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (10)

  • Visual Analogue Scale

    Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

    Before Treatment

  • Visual Analogue Scale

    Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).

    8 week after treatment

  • Isokinetic Muscle Strength Measure

    Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.

    Before Treatment

  • Isokinetic Muscle Strength Measure

    Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.

    8 week after treatment

  • The hand grip strength

    The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.

    Before Treatment

  • The hand grip strength

    The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.

    8 week after treatment

  • The finger pinch strength

    Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.

    Before Treatment

  • The finger pinch strength

    Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.

    8 week after treatment

  • Boston Carpal Tunnel Syndrome Questionnaire

    This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.

    Before Treatment

  • Boston Carpal Tunnel Syndrome Questionnaire

    This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.

    8 week after treatment

Secondary Outcomes (4)

  • Disabilities of the Arm, Shoulder end Hand Questionnaire

    Before Treatment

  • Disabilities of the Arm, Shoulder end Hand Questionnaire

    8 week after treatment

  • Short Form-36 Quality of Life Scale

    Before Treatment

  • Short Form-36 Quality of Life Scale

    8 week after treatment

Study Arms (3)

Splint

ACTIVE COMPARATOR

Patients in Group 1 will be applied to only static wrist splint treatment for 8 week.

Device: Static wrist splint treatment

Tendon and nerve gliding exercise

ACTIVE COMPARATOR

Patients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week.

Device: Static wrist splint treatmentOther: Tendon and nerve gliding exercises

local steroid injection

ACTIVE COMPARATOR

Patients in Group 3 will be applied to local steroid injection to wrist in addition to static wrist splint treatment for 8 week.

Device: Static wrist splint treatmentDrug: Wrist local steroid injection

Interventions

Static wrist splint treatmentDEVICE

Static wrist splint (volar wrist cock-up orthosis): It extends from the proximal of the metacarpophalangeal (MCP) joint to the distal 2/3 of the forearm, supports the wrist from the volar face. It stabilizes the wrist in 20-30 degrees of dorsiflexion and restricts wrist movements. It allows movement of the MCP joints. Patients will be asked to wear this splint continuously at night and for at least 4 hours during the day for 8 weeks.

SplintTendon and nerve gliding exerciselocal steroid injection
Tendon and nerve gliding exercisesOTHER

Tendon and nerve gliding exercises will be applied 5 sessions a day for 8 weeks. Each session will hold 10 repetitions and approximately 7 seconds in each exercise position. These exercises involve a sequence of finger movements (for tendon gliding) and wrist and fingers movements (for median nerve gliding).

Tendon and nerve gliding exercise
Wrist local steroid injectionDRUG

Wrist local steroid injection: After proper area cleaning with povidone solution, 1ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml) steroid injection will be applied around the median nerve with a 22 G injector from ulnar side of the wrist proximal crease under ultrasound guidance.

local steroid injection

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild to moderate CTS confirmed by Electromyography
  • Clinically, at least one of the symptoms of hand-wrist pain, numbness, night pain should be present.
  • Clinically, at least one of the Tinel, Phalen, and median nerve compression findings should be present.

You may not qualify if:

  • Having a history of trauma and operation on the wrist.
  • Patients who have had previous injections from the wrist
  • Patients with thyroid diseases, diabetes mellitus, systemic peripheral neuropathy and cervical radiculopathy
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 27, 2022

Study Start

August 1, 2022

Primary Completion

July 30, 2023

Study Completion

May 27, 2025

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations

TU(1)