NCT07644884

Brief Summary

Adhesive capsulitis, also known as frozen shoulder, is a musculoskeletal condition that causes significant shoulder pain and restricted joint mobility. It affects the glenohumeral joint and is commonly seen in individuals between the ages of 40 and 60 year. It affects 3 to 5% of the general population with a higher prevalence among females and patients with diabetes or thyroid disorders. Adhesive capsulitis progresses in four stages: painful, freezing, frozen, and thawing, and the condition may persist for 1 to 2 years. This study aims to determine the effects of Deltoid Strengthening Exercises on pain, range of motion, muscle strength and disability in patients with Adhesive Capsulitis.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet 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 Progress6%
Jun 2026Nov 2026

First Submitted

Initial submission to the registry

June 1, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 1, 2026

Last Update Submit

June 8, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain-Numeric Pain Rating Scale

    In current study, patients with Adhesive Capsulitis having Numeric Pain Rating Scale (NPRS) score of greater or equal to 3 and less than 7 will be included. Numeric Pain Rating Scale (NPRS) is used to measure pain levels in all subjects. NPRS is self-reported, single-dimensional 11 point scale between 0 and 10. The NPRS has a moderate test-retest reliability in patients with a primary complaint of shoulder pain with ICC=0.74, MCID of 1.1 points and MDC of 2.5 points.

    upto 4 weeks

  • Disability-Shoulder Pain and Disability Index

    Patients with Adhesive Capsulitis having Shoulder Pain and Disability Index (SPADI) score of 41 to 60 will be included in the current study. The Shoulder Pain and Disability Index (SPADI) is used for measuring the level of disability in patients. This self-administered index consists of 13 items divided into two subscales: 5 items for pain and 8 items for disability. It is a practical outcome measure that will be completed by patients in less than 5 min and will be scored by clinician. It has a high internal consistency with Cronbach α typically exceeding 0.90 and a good test-retest reliability with ICC values ranging from 0.84 to 0.95. When the SPADI is used more than once on the same subject i.e. at initial consultation and then at discharge, the minimal detectible change (MDC 95%) is 18 points

    upto 4 weeks

  • Range of motion-Universal Goniometer

    Adhesive capsulitis' patients have a capsular pattern of restriction of glenohumeral joint. Universal goniometer (UG) will be used to measure external rotation, internal rotation, abduction and flexion. Universal Goniometer is defined as a high-resolution plastic goniometer that permits observation of the axis of motion and ROM of the joint being measured. UG has been considered the gold standard for clinical assessment of ROM. It has a good reliability for AROM with ICC ranging from 0.53 to 0.65, and SEM calculated to be 14-25.

    upto 4 weeks

Study Arms (2)

Deltoid strengthening exercises

EXPERIMENTAL

Deltoid Strengthening Exercises: * Deltoid Isometrics * Dumb bell Strengthening Exercises * Theraband Strengthening Exercises

Other: Exercises

Standard Physical therapy

ACTIVE COMPARATOR

Ultrasound Glenohumeral Distraction Manual therapy Codman's Pendulum Exercise Finger Ladder exercise Wand Exercise

Other: Standard Physical therapy

Interventions

a) Deltoid Isometrics The following isometrics of Deltoid will be performed: * Anterior Deltoid: Front Raise Isometrics Isometrics of Anterior Deltoid will be performed. The arm is raised to 90 shoulder flexion. The elbows are slightly flexed (5 degrees) while the subject is pushing isometric upward against manual resistance provided by the therapist * Middle Deltoid: Lateral Raise Isometrics The arm will be abducted to the horizontal position. The humerus is slightly flexed about thirty degrees while the elbows are kept in a static, slightly flexed position. The arms are lifted isometric upward against resistance provided by the therapist * Posterior Deltoid: Reverse Fly Isometrics The participant sits on a chair with trunk bent from the horizontal with the arms pointing toward the floor. The arms are raised until the upper arms are horizontal, while the elbows were in a static, slightly flexed position. The subject pushes upward against resistance provided by the therapist

Deltoid strengthening exercises

Ultrasound Glenohumeral Distraction Manual therapy Codman's Pendulum Exercise Finger Ladder exercise Wand Exercise

Standard Physical therapy

Eligibility Criteria

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

You may qualify if:

  • Both male and female gender
  • Subjects with age ranging from 40 to 60 years
  • Subjects with stage II and III adhesive capsulitis

You may not qualify if:

  • Subjects with rotator cuff tears
  • Subjects with glenohumeral arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Nakandala P, Nanayakkara I, Wadugodapitiya S, Gawarammana I. The efficacy of physiotherapy interventions in the treatment of adhesive capsulitis: A systematic review. J Back Musculoskelet Rehabil. 2021;34(2):195-205. doi: 10.3233/BMR-200186.

    PMID: 33185587BACKGROUND
  • Seher Z, Goher N, Hamid A, Latif U, Bukhari A, Rafique H, et al. Prevalence of adhesive capsulitis among diabetics and non-diabetics with shoulder pain in general population: prevalence of adhesive capsulitis. Pakistan Journal of Health Sciences. 2023:67-71.

    BACKGROUND
  • Rawat P, Eapen C, Seema KP. Effect of rotator cuff strengthening as an adjunct to standard care in subjects with adhesive capsulitis: A randomized controlled trial. J Hand Ther. 2017 Jul-Sep;30(3):235-241.e8. doi: 10.1016/j.jht.2016.10.007. Epub 2016 Nov 21.

    PMID: 27884497BACKGROUND
  • Sung JH, Lee JM, Kim JH. The Effectiveness of Ultrasound Deep Heat Therapy for Adhesive Capsulitis: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Feb 7;19(3):1859. doi: 10.3390/ijerph19031859.

    PMID: 35162881BACKGROUND
  • Ramirez J. Adhesive Capsulitis: Diagnosis and Management. Am Fam Physician. 2019 Mar 1;99(5):297-300.

    PMID: 30811157BACKGROUND
  • Heinecke ML, Thuesen ST, Stow RC. Graston technique on shoulder motion in overhead athletes. J Undergrad Kinesiol Res. 2014;10(1):27-39.

    BACKGROUND
  • Mustafa Z, Zafar MA, Zafar S, Aslam F, Nasir A, Ahmad M, et al. Prevalence of adhesive capsulitis in non-diabetic participants within age 50-70 years in Multan. International Journal of Natural Medicine and Health Sciences. 2024;3(2):40-2.

    BACKGROUND
  • Reinold MM, Macrina LC, Wilk KE, Fleisig GS, Dun S, Barrentine SW, Ellerbusch MT, Andrews JR. Electromyographic analysis of the supraspinatus and deltoid muscles during 3 common rehabilitation exercises. J Athl Train. 2007 Oct-Dec;42(4):464-9.

    PMID: 18174934BACKGROUND
  • Moser T, Lecours J, Michaud J, Bureau NJ, Guillin R, Cardinal E. The deltoid, a forgotten muscle of the shoulder. Skeletal Radiol. 2013 Oct;42(10):1361-75. doi: 10.1007/s00256-013-1667-7. Epub 2013 Jun 20.

    PMID: 23784480BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Noha Arshad, MSPT*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 12, 2026

Study Start

June 6, 2026

Primary Completion (Estimated)

October 6, 2026

Study Completion (Estimated)

November 6, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share