NCT07074509

Brief Summary

This study aimed to compare the effectiveness of manual therapy and extracorporeal shock wave therapy in patients with mild to moderate carpal tunnel syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

July 10, 2025

Last Update Submit

July 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    A visual analogue scale (VAS) via 11-point numerical pain rating scale (0=no pain to 10=maximum pain) was used to assess the current level of pain and hand discomfort

    3 months post-procedure

Secondary Outcomes (1)

  • Boston Questionnaire

    3 months post-procedure

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Patients were treated by manual therapy in the form of nerve gliding, soft tissue release, and carpal bone mobilization, three sessions per week for 4weeks.

Other: Manual therapy

Group 2

EXPERIMENTAL

Patients were treated by extracorporeal shock wave therapy. 4 sessions, one week apart, 2000 pulses per session, intensity 1.6 mj/mm, and frequency 8Hz.

Other: Extracorporeal shock wave therapy

Interventions

Patients were treated by manual therapy in the form of nerve gliding, soft tissue release, and carpal bone mobilization, three sessions per week for 4weeks.

Group 1

Patients were treated by extracorporeal shock wave therapy. 4 sessions, one week apart, 2000 pulses per session, intensity 1.6 mj/mm, and frequency 8Hz.

Group 2

Eligibility Criteria

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

You may qualify if:

  • Both sexes.
  • Patients with mild and moderate carpal tunnel syndrome (CTS).

You may not qualify if:

  • Severe cases of CTS.
  • History of carpal tunnel release surgery.
  • Steroid injection in carpal tunnel in the past 6 months.
  • Cases of thoracic outlet syndrome and cervical radiculopathy.
  • Pregnant females.
  • Systemic rheumatic diseases such as rheumatoid arthritis.
  • Hypothyroidism.
  • Patients with bleeding tendency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Musculoskeletal ManipulationsExtracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationUltrasonic TherapyDiathermyHyperthermia, Induced

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Rheumatology, Rehabilitation and Physical Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 20, 2025

Study Start

February 19, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations