Clinical trial NCT05391984: Effects of Activity Versus Structural Oriented Treatment Approach in Patients With Frozen Shoulder.
Official title: Effects of Activity Versus Structural Oriented Treatment Approach on Pain, Range of Motion, and Function in Patients With Frozen Shoulder.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frozen Shoulder
Keywords: frozen shoulder
manual therapy
proprioceptive neuromuscular facilitation
neuroplasticity
diabetes
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of activity versus structural oriented treatment approach on pain, range of motion, and function in diabetic patients with frozen shoulder.

Detailed description: Frozen shoulder, also known as adhesive capsulitis, is a condition of uncertain etiology, characterized by shoulder stiffness, severe pain, significant restriction of range of motions, and limitation in participation in socio-economical life. According to a concept, pain causes changes in the brain making it learn the non-use, and therefore, even after healing of peripheral structures has occurred, the brain may not be able to organize voluntary actions owing to the induced central changes. Physical therapy plays an important role to bring pain relief and return of functional motion in frozen shoulder and there are many approaches available that can be used but literature on treatments based on neuroplasticity is comparatively less.

According to the research available, neuroplasticity has been effective in treating frozen shoulder. Similarly, PNF, home exercises, and joint mobilizations have also proven to be effective. The effects of the activity related and structural-oriented treatment on the frozen shoulder has not been addressed in diabetic patients yet. More RCTs are required to determine the best treatment for managing adhesive capsulitis in diabetics. Therefore, this research will be conducted which will compare the activity-based approach and the conventional approach to treating frozen shoulder in diabetics. The results may open new aspects of treating frozen shoulder in diabetics which can be cost-effective as well.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with frozen shoulder, limited ROM, and pain in the shoulder region
* Patients with diabetes from 10+ years

Exclusion Criteria:

* History of headaches and dizziness
* Pain and limited ROM in the cervical spine
* Pain and limited ROM in temporomandibular joint

Primary outcomes:
measure: NPRS for pain
timeFrame: 4th week
measure: Goniometer for range of motion
timeFrame: 4th week
measure: SPADI for pain and disability
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Social security hospital, Kot Lakhpat
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Salman Bashir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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