- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482111
Comparison of Digital and Conventional Physical Therapy on Cost Effectiveness, Pain, and Disability in Adhesive Capsulitis
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lahore, Pakistan, 54000
- UIPT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Conventional Physical Therapy
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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.
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Experimental: Digital Physical Therapy (Tele-rehabilitation)
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity Measured by the Numeric Pain Rating Scale
Time Frame: 6 weeks
|
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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Arslan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adhesive Capsulitis
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Daniel G. RendeiroCompletedAdhesive Capsulitis of Shoulder | Frozen Shoulder | Shoulder Adhesive CapsulitisUnited States
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University of MalayaNot yet recruitingAdhesive Capsulitis of Shoulder
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Taipei Veterans General Hospital, TaiwanRecruitingAdhesive Capsulitis of ShoulderTaiwan
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Cairo UniversityNot yet recruitingAdhesive Capsulitis of Shoulder
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Health Education Research Foundation (HERF)RecruitingAdhesive Capsulitis of ShoulderPakistan
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Taif UniversityCompletedAdhesive Capsulitis of ShoulderSaudi Arabia
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Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
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Balikesir UniversityCompletedAdhesive Capsulitis of Shoulder
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Haytham M ElhafezCairo UniversitySuspendedAdhesive Capsulitis of the ShoulderEgypt
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Superior UniversityActive, not recruitingAdhesive Capsulitis, ShoulderPakistan
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