NCT07482111

Brief Summary

Adhesive capsulitis is a common musculoskeletal condition characterized by shoulder pain, progressive stiffness, and functional limitation, significantly affecting activities of daily living and quality of life. Physical therapy plays a key role in the management of adhesive capsulitis through pain reduction, restoration of range of motion, and improvement of functional capacity. With the advancement of digital health technologies, digital physical therapy interventions such as tele-rehabilitation and app-guided exercise programs have emerged as potential alternatives to conventional in-person therapy. However, evidence comparing the clinical outcomes and cost-effectiveness of digital physical therapy with conventional physical therapy remains limited, particularly in patients with adhesive capsulitis. Therefore, this randomized controlled trial aims to compare the effects of digital physical therapy and conventional physical therapy on pain intensity, functional disability, and cost-effectiveness among patients diagnosed with adhesive capsulitis. Participants will be randomly allocated to either a digital physical therapy group, receiving supervised exercise guidance and monitoring through digital platforms, or a conventional physical therapy group receiving standard in-clinic physiotherapy interventions. Pain and disability outcomes will be assessed using validated outcome measures such as the Visual Analog Scale and the Shoulder Pain and Disability Index. Cost-effectiveness will be evaluated by comparing treatment-related direct and indirect costs between both groups. The findings of this study will help determine whether digital physical therapy is a clinically effective and economically viable alternative to conventional physiotherapy for managing adhesive capsulitis, potentially improving accessibility to rehabilitation services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 10, 2026

Last Update Submit

March 15, 2026

Conditions

Keywords

PainPhysical Therapy ModalitiesRange of MotionArticularShoulder joint

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Measured by the Numeric Pain Rating Scale

    Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point self-reported scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will be asked to rate their average pain intensity over the past 24 hours related to their condition. Score Interpretation: Minimum score: 0 (no pain) Maximum score: 10 (worst imaginable pain) Higher scores indicate greater pain intensity (worse outcome).

    6 weeks

Study Arms (2)

Digital Physical Therapy (Tele-rehabilitation)

EXPERIMENTAL
Other: Digital Physical Therapy (Tele-rehabilitation Program)Other: Conventional Physiotherapy Rehabilitation Program

Conventional Physical Therapy

ACTIVE COMPARATOR
Other: Conventional Physiotherapy Rehabilitation Program

Interventions

Participants allocated to this group will receive a structured tele-rehabilitation program supervised remotely by a licensed physiotherapist through video-conferencing platforms. The program will include shoulder mobility exercises, capsular stretching, strengthening exercises for the rotator cuff and scapular stabilizer muscles, and functional training to improve shoulder movement and reduce pain. Participants will attend three supervised online sessions per week for six weeks. Instruction on proper exercise technique and progression will be provided, and participants will also be encouraged to perform prescribed home exercises between sessions. Regular virtual monitoring and feedback will be provided to ensure adherence and correct performance of exercises.

Digital Physical Therapy (Tele-rehabilitation)

Participants in this group will receive standard in-clinic physiotherapy supervised by licensed physiotherapists. The intervention will include therapeutic exercises focusing on shoulder mobility, capsular stretching, strengthening exercises for the rotator cuff and scapular stabilizers, and manual therapy techniques such as joint mobilization to improve shoulder range of motion and reduce pain. Treatment sessions will be conducted three times per week for six weeks at the physiotherapy clinic. Participants will also receive instructions for home exercises to support recovery and improve functional mobility.

Conventional Physical TherapyDigital Physical Therapy (Tele-rehabilitation)

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The study included male and female participants aged 35-55 years who had received a clinical diagnosis of adhesive capsulitis from an orthopedic surgeon or a physical therapist. The study accepted participants who had experienced pain for three months or longer and showed increasing difficulties with both active and passive movements, particularly during external rotation. The participants had to comprehend the DASH and NPRS questionnaires on their own and provide their responses without assistance

You may not qualify if:

  • The study excluded participants who had undergone any shoulder surgery or who had experienced any traumatic incident within the past six months or had severe mental health disorders, significant cognitive impairments, systemic inflammatory or neurological conditions that affected their upper limbs, or electronic implants that would be affected by electrical treatment, and diabetes mellitus that was not under control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UIPT

Lahore, 54000, Pakistan

Location

MeSH Terms

Conditions

BursitisPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
PRINCIPAL INVESTIGATOR
PI Title
Dr.Aqsa Majeed

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 19, 2026

Study Start

November 3, 2025

Primary Completion

February 27, 2026

Study Completion

February 27, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations