NCT06664437

Brief Summary

Background: Adhesive capsulitis (AC) is a common musculoskeletal disorder affecting the functional activities of daily living through capsular restriction. There is a limited knowledge concerning neural restriction as a source of movement limitation in patients with AC other than the enriched knowledge regarding joint mobilization techniques in addressing mobility restrictions for patients with AC. Objectives: This study was designed to determine the efficacy of adding median nerve mobilization to the glenohumeral (GH) joint mobilization techniques on shoulder pain intensity, functional disability and active and passive ROM of glenohumeral abduction and external rotation in patients with AC. Methods: Thirty patients with primary AC with their ages ranged from 40 to 70 years old were included and randomly assigned into two groups. Group A received GH joint mobilization techniques while patients in group B received median nerve mobilization in addition to GH joint mobilization. Both groups received conventional physical therapy which included hot pack for 10 minutes, pendulum exercise and stretching exercises. Treatment sessions were three per week for six weeks. Patients were assessed pre and post interventional procedures for shoulder pain intensity by visual analogue scale (VAS), functional disability by shoulder pain and disability index (SPADI) and active and passive ROM of GH abduction and external rotation by conventional goniometer

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 May 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

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 27, 2024

Last Update Submit

October 27, 2024

Conditions

Keywords

Adhesive capsulitisShoulder disabilityJoint mobilization

Outcome Measures

Primary Outcomes (1)

  • glnohumeral ROM

    Assessment of shoulder ROM: Conventional goniometer was used to assess active and passive shoulder ROM. It is a highly reliable method (0.94-0.98 test-retest reliability. Patients in this study were assessed for active and passive ROM of glenohumeral abduction and external rotation (with the arm at 0 degrees of abduction) . All Measurements of shoulder ROM were performed three times, and the mean values were used for the statistical analysis Assessment of GH abduction and external rotation ROM: For measurement of GH abduction ROM, the patient was in supine lying with shoulder in neutral position; the therapist aligned the fulcrum of the goniometer at the anterior acromial aspect and the movable arm along the anterior aspect of the humerus and the stationary arm was parallel to midline of sternum, the patient was asked to actively elevate his arm in abduction as much as he could, and the reading of the goniometer was noted and was recorded after taking the average of three trials. T

    At baseline and after 6 weeks

Secondary Outcomes (2)

  • glenohumeral disability

    At baseline and after 6 weeks

  • glenohumeral pain intensity

    At baseline and after 6 weeks

Study Arms (2)

group A

EXPERIMENTAL

Group (A): GH Joint mobilization techniques (Posterior, Inferior glide). Patients were in supine lying position during the whole treatment. The techniques were performed in a rhythmic way, with 2 seconds of glide distraction and then a 2-second break. Each technique was done for 2 minutes \[36\]. Posterior gliding was performed by maintaining lateral humeral distraction with the glenohumeral in abduction range and the scapula stabilized. Then the therapist applied posterior glide in an oscillating manner. For inferior gliding, with the scapula stabilized, the therapist maintained lateral humeral distraction while applying inferior glide in the resting position of the glenohumeral joint. Patients had 3 sessions of joint mobilization per week for 6 weeks.

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Group (B)

EXPERIMENTAL

Median nerve mobilization techniques (ULLT-1) in addition to GH joint mobilization

Other: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

Patients were in supine lying position during the whole treatment. The techniques were performed in a rhythmic way, with 2 seconds of glide distraction and then a 2-second break. Each technique was done for 2 minutes \[36\]. Posterior gliding was performed by maintaining lateral humeral distraction with the glenohumeral in abduction range and the scapula stabilized. Then the therapist applied posterior glide in an oscillating manner. For inferior gliding, with the scapula stabilized, the therapist maintained lateral humeral distraction while applying inferior glide in the resting position of the glenohumeral joint. Patients had 3 sessions of joint mobilization per week for 6 weeks.

Also known as: joint mobilization
Group (B)group A

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients from both genders were included in this study if they would have primary AC with their ages between 40 and 70 years old and complained of pain, stiffness, and limitation of passive shoulder lateral rotation, abduction, and internal rotation of greater than 50%compared to the non-affected side for at least 3 months. Patients with positive (ULTT-1) were also included in this study .

You may not qualify if:

  • Patients were excluded if they would have stroke, Parkinson's diseases that interfere with shoulder muscles activity, diabetes, traumatic shoulder conditions, glenohumeral osteoarthritis confirmed by x-ray, previous surgery and manipulation under anesthesia of the affected shoulder. Patients with restricted passive elbow extension ROM were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Sattam bin Abdulaziz University

Riyadh, Alkharj, 11942, Saudi Arabia

Location

Related Publications (5)

  • Yang JL, Chang CW, Chen SY, Wang SF, Lin JJ. Mobilization techniques in subjects with frozen shoulder syndrome: randomized multiple-treatment trial. Phys Ther. 2007 Oct;87(10):1307-15. doi: 10.2522/ptj.20060295. Epub 2007 Aug 7.

  • Schmid AB, Brunner F, Luomajoki H, Held U, Bachmann LM, Kunzer S, Coppieters MW. Reliability of clinical tests to evaluate nerve function and mechanosensitivity of the upper limb peripheral nervous system. BMC Musculoskelet Disord. 2009 Jan 21;10:11. doi: 10.1186/1471-2474-10-11.

  • Akhtar M, Karimi H, Gilani SA, Ahmad A, Raza A. The effectiveness of routine physiotherapy with and without neuromobilization on pain and functional disability in patients with shoulder impingement syndrome; a randomized control clinical trial. BMC Musculoskelet Disord. 2020 Nov 21;21(1):770. doi: 10.1186/s12891-020-03787-0.

  • Joshi D, Shah S, Shinde SB, Patil S. Effect of Neural Tissue Mobilization on Sensory-Motor Impairments in Breast Cancer Survivors with Lymphedema: An Experimental Study. Asian Pac J Cancer Prev. 2023 Jan 1;24(1):313-319. doi: 10.31557/APJCP.2023.24.1.313.

  • Hegazy MMA, Mahmoud WSE, Ahmed AS. Slider Versus Tensioner Median Nerve Mobilization in Patients With Frozen Shoulder Randomized Controlled Comparative Study. Physiother Res Int. 2026 Jan;31(1):e70164. doi: 10.1002/pri.70164.

MeSH Terms

Conditions

Bursitis

Interventions

ExerciseDosage Forms

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventional procedures: Group (A): GH Joint mobilization techniques (Posterior, Inferior glide). Patients were in supine lying position during the whole treatment. The techniques were performed in a rhythmic way, with 2 seconds of glide distraction and then a 2-second break. Each technique was done for 2 minutes \[36\]. Posterior gliding was performed by maintaining lateral humeral distraction with the glenohumeral in abduction range and the scapula stabilized. Then the therapist applied posterior glide in an oscillating manner. For inferior gliding, with the scapula stabilized, the therapist maintained lateral humeral distraction while applying inferior glide in the resting position of the glenohumeral joint. Patients had 3 sessions of joint mobilization per week for 6 weeks. Group (B): Median nerve mobilization techniques (ULLT-1) in addition to GH joint mobilization Patients also in this group remained in supine lying position. Median nerve mobilization was performed by placin
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

October 27, 2024

First Posted

October 29, 2024

Study Start

May 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

No need

Locations