NCT07797023

Brief Summary

Cubital tunnel syndrome occurs when the ulnar nerve is compressed or irritated near the elbow. It can cause elbow or forearm pain, numbness or tingling in the ring and little fingers, hand weakness, and difficulty performing daily activities. This randomized clinical trial will compare two conservative physiotherapy programs for adults with mild to moderate cubital tunnel syndrome. A total of 56 participants will be assigned by computer-generated randomization to one of two groups. Group A will receive soft tissue mobilization combined with ulnar nerve-specific strengthening and nerve-gliding exercises. Group B will receive soft tissue mobilization alone. Both groups will also receive education about activity modification, ergonomic correction, and avoiding prolonged elbow bending. Treatment will be provided three times per week for four weeks, for a total of 12 sessions. Participants will be assessed before treatment and at the end of the fourth week. The main outcomes will be pain intensity, measured using the Numeric Pain Rating Scale, and upper-limb disability, measured using the Disabilities of the Arm, Shoulder and Hand questionnaire. The study aims to determine whether adding ulnar nerve-specific strengthening and nerve-gliding exercises to soft tissue mobilization provides greater improvement in pain and upper-limb function than soft tissue mobilization alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

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

October 22, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Last Updated

September 4, 2026

Status Verified

September 1, 2026

Enrollment Period

8 months

First QC Date

August 27, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

Cubital Tunnel SyndromeDisability EvaluationPhysical Therapy ModalitiesRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Change in Pain Intensity Measured by the Numeric Pain Rating Scale

    Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS). Participants will rate their average pain during the previous 24 hours on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates the "worst possible pain." Lower scores represent less pain. Change will be calculated by comparing the baseline score with the score recorded after the four-week intervention.

    Baseline and immediately after the 4-week intervention

  • Change in Upper-Limb Disability Measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire

    Upper-limb disability will be assessed using the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Items evaluate difficulty performing daily activities, symptom severity, and the effect of the condition on social and functional participation. The total score ranges from 0 to 100, where 0 indicates no disability and 100 indicates the greatest disability. Lower scores represent better upper-limb function. Change will be calculated by comparing baseline and post-intervention scores.

    Baseline and immediately after the 4-week intervention

Study Arms (2)

Soft Tissue Mobilization Plus Ulnar Nerve-Specific Exercises

EXPERIMENTAL

Participants will receive soft tissue mobilization targeting the medial elbow and flexor-pronator muscles, combined with ulnar nerve-specific strengthening and nerve-gliding exercises. Manual techniques will include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. Strengthening will target the wrist flexors, forearm stabilizers, intrinsic hand muscles, and grip muscles. Participants will receive three sessions per week for four weeks (12 sessions), with each session lasting approximately 30-40 minutes. They will also receive activity-modification and ergonomic education and perform prescribed exercises at home once daily.

Other: Ulnar Nerve-Specific Strengthening and Nerve-Gliding Exercises

Soft Tissue Mobilization Alone

ACTIVE COMPARATOR

Participants will receive standardized soft tissue mobilization targeting the medial elbow and flexor-pronator muscles. Techniques will include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. Participants will not receive ulnar nerve-specific strengthening or nerve-gliding exercises during the intervention period. Treatment will be provided three times per week for four weeks (12 sessions), with each session lasting approximately 20-30 minutes. Participants will also receive education regarding activity modification, ergonomic correction, and avoidance of prolonged elbow flexion.

Other: Soft Tissue Mobilization

Interventions

A physiotherapist will apply standardized manual soft tissue techniques to the medial elbow and flexor-pronator muscle region of the affected upper limb. Techniques will include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. The intervention is intended to reduce muscular and fascial restrictions, improve tissue extensibility and local circulation, and decrease mechanical irritation around the cubital tunnel. Treatment will be administered three times per week for four weeks, for a total of 12 sessions. This intervention will be provided to participants in both study arms.

Soft Tissue Mobilization Alone

Participants will perform progressive strengthening exercises targeting the wrist flexors, forearm stabilizers, intrinsic hand muscles, and grip musculature. Exercises will include resisted wrist flexion, hand-grip training, finger abduction and adduction, thumb opposition, and resisted finger flexion, generally performed in two to three sets of 10-15 repetitions. Controlled ulnar nerve-gliding exercises will also be performed within a pain-free range. Supervised treatment will be provided three times per week for four weeks, and participants will be instructed to complete the prescribed strengthening and nerve-gliding exercises at home once daily.

Soft Tissue Mobilization Plus Ulnar Nerve-Specific Exercises

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with mild to moderate cubital tunnel syndrome (ulnar neuropathy at the elbow)
  • Patients having symptoms for more than one month
  • Patients who are willing to participate and provide informed consent.
  • Patients who are able to follow instructions and complete the treatment protocol.

You may not qualify if:

  • Patients with a history of elbow surgery
  • Patients with severe neurological deficits (e.g., advanced muscle atrophy or complete nerve palsy)
  • Patients with fracture or dislocation of the elbow joint
  • Patients with systemic neurological disorders (e.g., stroke, multiple sclerosis)
  • Patients with rheumatoid arthritis or other inflammatory joint diseases
  • Patients currently receiving other physiotherapy or invasive treatments for the same condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy Departments of Nawaz Sharif Social Security Hospital, Multan Road, Lahore, and MoveNow Physiotherapy and Rehabilitation Centre, Lahore.

Lahore, 54000, Pakistan

Location

Related Publications (2)

  • Wolny T, Wieczorek M. Real Versus Sham-Based Neurodynamic Techniques in the Treatment of Cubital Tunnel Syndrome: A Randomized Placebo-Controlled Trial. J Clin Med. 2025 Mar 19;14(6):2096. doi: 10.3390/jcm14062096.

    PMID: 40142903BACKGROUND
  • Deflorin C, Hohenauer E, Stoop R, van Daele U, Clijsen R, Taeymans J. Physical Management of Scar Tissue: A Systematic Review and Meta-Analysis. J Altern Complement Med. 2020 Oct;26(10):854-865. doi: 10.1089/acm.2020.0109. Epub 2020 Jun 24.

    PMID: 32589450BACKGROUND

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Ulnar NeuropathiesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesUlnar Nerve Compression SyndromesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Ahmed Umair

    Riphah International University

    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
SPONSOR INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

October 22, 2025

Primary Completion

June 14, 2026

Study Completion

July 15, 2026

Last Updated

September 4, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations