NCT07854288

Brief Summary

Frozen shoulder has been described as a painful condition associated with stiffness and difficulty in sleeping on the affected side. People with this condition have difficulty in dressing, overhead movements and sleep disturbance. It occurs in 2 - 5% of general adult population, 10 - 15% of the people with diabetes. It mainly affects the individuals of 35 - 65 years of age with female predominance. Frozen shoulder is characterized by fibroproliferative tissue fibrosis whereby fibroblasts, producing predominantly type I and type III collagen, transform into myofibroblasts, which is accompanied by inflammation, resulting in shoulder capsular fibrotic contractures and the associated clinical stiffness. There are two frozen shoulder syndromes, namely primary syndrome and secondary syndrome. In primary or idiopathic syndrome, frozen shoulder that occurs spontaneously or directly without knowing the causative factors. Primary syndrome occurs due to a chronic inflammatory response with fibroblast proliferation which can actually be a response from an abnormal immune system. Secondary syndromes occur due to several triggers such as trauma that can cause shoulder injuries or surgery associated with the onset of other conditions such as diabetes mellitus, autoimmune diseases and cardiovascular disorders. The clinical presentation of frozen shoulder typically progresses through three stages: the freezing stage, where the shoulder becomes painful and progressively stiff over two to nine months; the frozen stage, characterized by significant stiffness and reduced pain over four to twelve months; and the thawing stage, where gradual improvement in shoulder mobility occurs over five to twenty-four months. The condition can be severely debilitating, impacting daily activities and overall quality of life. Adhesive capsulitis treatment primarily consists of pain relief and physical therapy techniques. Anti-inflammatory medication is helpful in pain relief, so that mobility interventions can be initiated. Therapeutic modalities include Transcutaneous Electrical Nerve Stimulation (TENS), Interferential Therapy (IFT), Ultrasound, Short Wave Diathermy (SWD) etc, and the physical therapy exercises such as stretching, Codman exercise can be used. Exercises which may be active, passive or active assisted, play a crucial role in the early rehabilitation of these patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress73%
May 2026Dec 2026

Study Start

First participant enrolled

May 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 27, 2026

Last Update Submit

September 27, 2026

Conditions

Keywords

PianDisabilityAdhesive CapsulitisMobilization

Outcome Measures

Primary Outcomes (3)

  • Numeric pain rating scale (NPRS)

    The Numeric Pain Rating Scale (NPRS) is a widely used tool designed to assess pain intensity in both clinical and research settings. It consists of an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 indicates the "worst imaginable pain." NPRS is a quick and straightforward method, commonly used to track changes in pain over time, particularly in musculoskeletal and postoperative populations

    Baseline; Week 3; Week 6

  • Universal Goniometer

    The goniometer is a widely used instrument in clinical and rehabilitation settings to measure joint angles and assess the range of motion (ROM). It helps clinicians monitor progress and identify movement limitations in patients with musculoskeletal conditions.

    Baseline; Week 3; Week 6

  • Shoulder pain and disability index

    It is a self-administered questionnaire designed to evaluate pain and functional impairment related to shoulder disorders. It consists of 13 items, divided into pain and disability subscales, and is often used in both clinical practice and research.

    Baseline; Week 3; Week 6

Study Arms (2)

Group A

EXPERIMENTAL

Maitland mobilization combined with Stroking release technique of rotator cuff muscle

Other: Maitland mobilization combined with Stroking release technique

Group B

ACTIVE COMPARATOR

Maitland mobilization

Other: Maitland Mobilization, along with baseline treatment

Interventions

Maitland mobilization combined with Stroking release technique of Rotator cuff muscles, along with baseline treatment * Maitland mobilization: * Perform using Grades III and IV glides (anterior, posterior, inferior) targeting the glenohumeral joint. * Aimed at reducing stiffness and improving range of motion. * 3 sets for 30 sec. * Rotator cuff muscle release: (Stroking release technique) * Manual muscle release of supraspinatus, Infraspinatus, Subscapularis and Teres minor for 15 minutes. (2-3 reps per muscle and 1 set per muscle per session) * It will help to reduce muscle tightness and improve mobility 1. Supraspinatus release: The patient will be in sitting or side-lying. Palpate just above the spine of the scapula. Use thumb pressure along muscle fibres. Move from distal end to proximal. 2. Infraspinatus release: The patient will be in a sitting position. Locate the muscle below the spine of the scapula. Apply thumb pressure along muscle fibres or cross friction.

Group A

Maitland Mobilization, along with baseline treatment No additional soft tissue work was performed on the rotator cuff muscles. Baseline treatment will be: Hot pack and TENS for 10 minutes Scapular mobilization: Scapular mobilization is performed in a side-lying with the patient relaxed. The therapist passively mobilizes the scapula in different directions to improve scapulothoracic rhythm and reduce stiffness. Techniques used will be: * Scapular elevation, depression * Scapular protraction, retraction 3 sets of 6-8 mobilizations in each direction. 1 session per day and 3 sessions per week (26). Codman exercises: Codman exercises help promote passive motion of the shoulder joint without activating the shoulder musculature, reducing pain and improving mobility. Patient leans forward, hanging the affected arm freely. Small pendulum-like motions are performed in: * Circular motion * Forward back swing * Side-to-side swing 4 sets of 6-8 reps in each direction

Group B

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 40 to 60 years
  • Stage 2 and 3 Frozen shoulder
  • Positive capsular pattern
  • Positive Apley's scratch test
  • Unilateral Frozen Shoulder

You may not qualify if:

  • Rotator cuff disease
  • Post CABG
  • Post stroke frozen shoulder
  • Fracture of shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, 54000, Pakistan

RECRUITING

Related Publications (5)

  • Eybye MN, Madsen SD, Schultz ANO, Nim CG. Database coverage and their use in systematic reviews regarding spinal manipulative therapy: an exploratory study. Chiropr Man Therap. 2022 Dec 19;30(1):57. doi: 10.1186/s12998-022-00468-8.

    PMID: 36536437BACKGROUND
  • Deodato M, Martini M, Buoite Stella A, Citroni G, Ajcevic M, Accardo A, Murena L. Inertial Sensors and Pressure Pain Threshold to Evaluate People with Primary Adhesive Capsulitis: Comparison with Healthy Controls and Effects of a Physiotherapy Protocol. J Funct Morphol Kinesiol. 2023 Oct 6;8(4):142. doi: 10.3390/jfmk8040142.

    PMID: 37873901BACKGROUND
  • Satpute K, Reid S, Mitchell T, Mackay G, Hall T. Efficacy of mobilization with movement (MWM) for shoulder conditions: a systematic review and meta-analysis. J Man Manip Ther. 2022 Feb;30(1):13-32. doi: 10.1080/10669817.2021.1955181. Epub 2021 Aug 1.

    PMID: 34334099BACKGROUND
  • Phansopkar P, Qureshi MI. Impact of Spencer Technique on Pain, Range of Motion, and Functional Disability in Patients With Frozen Shoulder: A Pilot Study. Cureus. 2024 Jan 30;16(1):e53263. doi: 10.7759/cureus.53263. eCollection 2024 Jan.

    PMID: 38435910BACKGROUND
  • Phansopkar P, Qureshi MI. An Integrated Physical Therapy Using Spencer's Technique in the Rehabilitation of a Patient With a Frozen Shoulder: A Case Report. Cureus. 2023 Jun 30;15(6):e41233. doi: 10.7759/cureus.41233. eCollection 2023 Jun.

    PMID: 37529524BACKGROUND

MeSH Terms

Conditions

BursitisYaws

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesTreponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Muhammad Umar Hasnain, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Shakil ur Rehman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 2, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations