CClinicalTrials.gg
CompletedNCT07797023Updated Sep 4, 2026

Comparative Efficacy of Soft Tissue Mobilization and Ulnar Nerve-Specific Strengthening Exercises in Patients With Cubital Tunnel Syndrome

An interventional study of Soft Tissue Mobilization and Ulnar Nerve-Specific Strengthening and Nerve-Gliding Exercises in Cubital Tunnel Syndrome, sponsored by Hamna Sarfraz. Completed at 1 site in Pakistan. Open to participants aged 30 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Hamna Sarfraz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
30 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

Cubital tunnel syndrome, also known as ulnar neuropathy at the elbow, is a peripheral nerve entrapment disorder caused by compression or irritation of the ulnar nerve as it passes through the cubital tunnel. Individuals with this condition may experience pain around the medial elbow, numbness or tingling in the ring and little fingers, reduced grip strength, hand weakness, and limitations in upper-limb activities. Conservative physiotherapy is commonly recommended for mild to moderate cases; however, evidence comparing specific combinations of manual therapy and exercise remains limited.

This study is a randomized controlled trial designed to compare soft tissue mobilization combined with ulnar nerve-specific strengthening and nerve-gliding exercises with soft tissue mobilization alone. The study will recruit 56 adults aged 30-55 years with mild to moderate cubital tunnel syndrome. Participants will be recruited from the Physiotherapy Departments of Nawaz Sharif Social Security Hospital, Multan Road, Lahore, and MoveNow Physiotherapy and Rehabilitation Centre, Lahore, Pakistan.

Eligible participants will provide written informed consent before enrollment. They will then be allocated in a 1:1 ratio to Group A or Group B using a computer-generated randomization sequence, with 28 participants assigned to each group. Outcome assessment will be conducted at baseline and immediately after completion of the four-week intervention.

All participants will receive education regarding activity modification, ergonomic correction, and avoidance of prolonged elbow flexion. Group A will receive soft tissue mobilization together with ulnar nerve-specific strengthening and nerve-gliding exercises. Soft tissue mobilization will be applied to the medial elbow and flexor-pronator muscle region and may include myofascial release, longitudinal soft tissue mobilization, effleurage, and deep transverse friction massage. The strengthening component will target the wrist flexors, forearm stabilizers, intrinsic hand muscles, and grip musculature. Exercises will include resisted wrist flexion, hand-grip exercises, finger abduction and adduction, thumb opposition, and resisted finger flexion. Exercises will generally be completed in two to three sets of 10-15 repetitions. Controlled ulnar nerve-gliding exercises will be performed within a pain-free range. Participants in this group will also be advised to perform the prescribed strengthening and nerve-gliding exercises at home once daily.

Group B will receive soft tissue mobilization alone. Manual therapy will be applied to the medial elbow and flexor-pronator region using standardized techniques such as myofascial release, longitudinal mobilization, effleurage, and deep transverse friction massage. Participants in this group will not receive the ulnar nerve-specific strengthening or nerve-gliding program during the intervention period.

Both groups will attend three treatment sessions per week for four weeks, resulting in 12 sessions. Sessions will last approximately 30-40 minutes for Group A and 20-30 minutes for Group B.

Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale, ranging from 0, indicating no pain, to 10, indicating the worst possible pain. Upper-limb disability will be measured using the 30-item Disabilities of the Arm, Shoulder and Hand questionnaire, with scores ranging from 0, indicating no disability, to 100, indicating the greatest disability. The primary comparison will examine differences in changes in pain and upper-limb disability between baseline and the fourth week.

02

Conditions studied

  • Cubital Tunnel Syndrome

Keywords

  • Cubital Tunnel Syndrome
  • Disability Evaluation
  • Physical Therapy Modalities
  • Rehabilitation
03

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Soft Tissue Mobilization Plus Ulnar Nerve-Specific Exercises

    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

  • Active comparator
    Soft Tissue Mobilization Alone

    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

  • OtherSoft Tissue Mobilization

    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.

  • OtherUlnar Nerve-Specific Strengthening and Nerve-Gliding Exercises

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and immediately after the 4-week intervention

  2. 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.

    Time frame: Baseline and immediately after the 4-week intervention

06

Study locations

1 site
  • Physiotherapy Departments of Nawaz Sharif Social Security Hospital, Multan Road, Lahore, and MoveNow Physiotherapy and Rehabilitation Centre, Lahore.
    Lahore, 54000, Pakistan
07

References and documents

Publications

  • 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. PubMed 40142903 ↗
  • 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. PubMed 32589450 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07797023
Lead sponsor
Hamna Sarfraz
Responsible party
Hamna Sarfraz (Research Associate, University of Lahore) — Sponsor-investigator
First posted
Sep 1, 2026
Start date
Oct 22, 2025
Primary completion
Jun 14, 2026
Completion
Jul 15, 2026
Last update
Sep 4, 2026

Study contacts

Ahmed Umair
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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