- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06674408
Proprioceptive Exercises in Acute Adhesive Capsulitis
Effects of Proprioceptive and Hand Function Exercises in Management of Acute Adhesive Capsulitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adhesive capsulitis is one of the commonly encountered musculoskeletal disorders in physical therapy, and has debilitating effects on quality of life. Adhesive capsulitis has been traditionally classified into freezing, frozen and thawing stages, based on the disease course and natural history. The freezing stage, also known as the acute stage, is characterized by insidious and gradual loss of range of motion along with pain, especially at night. The acute stage lasts from the onset till anywhere from 2 to 9 months depending upon the intervention.
According to a recent systematic review, exercise therapy is beneficial for improving function and range of motion in patients with adhesive capsulitis, although to an uncertain degree of evidence. Another systematic review on occupational therapy interventions in musculoskeletal disorders found strong evidence for range of motion exercises and joint mobilizations when combined with steroid injections.
Hand function assessment is done mainly in neurological conditions and largely ignored in most musculoskeletal disorders of the shoulder and elbow, unless there is direct and significant impairment of the Hand function. However, literature supports the need of proximal stability in order to achieve distal mobility regardless of the activity being gross or fine motor. The physiological basis behind this are supported by electromyography studies showing the facilitation-inhibition effects of motor cortex neurons on spinal motor neuron pools of shoulder and distal upper limb musculature.
Descending commands directly influencing motor output have Corticomotoneuronal cells of the primary motor cortex as one of the sources, connecting monosynaptically with the motor neurons. Corticomotoneuronal cells give divergent outputs to muscles of the distal forelimb muscles, which raises the possibility that a single Corticomotoneuronal cells may represent even more complex output patterns. In addition to the musculature of the wrist and hand, those of the shoulder, elbow and trunk might be included in these complex patterns. For instance, during a reach and prehension task, Corticomotoneuronal cells influence muscles at multiple joints of the forelimb, through co-activation of proximal and distal muscles in coordinated, functional synergies which are in line with performance of different phases of the task.
Furthermore, the kinetic link model advocates for the proximal-to-distal sequencing when attempting to restore function, as efficient motion and muscle activation occur with rehabilitation of the entire neuromuscular system through multi-segment integration, rather than isolated treatment of the primarily involved area. According to the kinetic chain rehabilitation, by performing multi-segment exercises the involved muscles can be activated when facilitated by adjacent segments, developing appropriate shoulder function and motion (irradiation). Decreasing the role of the facilitating segments later in the progression increases the load and functional demand on the shoulder. Kinetic chain shoulder exercises, by employing the natural motor programs of motor control, focus on the neuromuscular system rather than on isolated movement and muscle activation.
Hand function exercises are not a routine part of rehabilitation protocol for management of adhesive capsulitis and literature is scarce for high quality evidence regarding efficacy and uniform dosage of Hand function and proprioceptive exercises to be included in the plan of care. A randomized study found no differences at 12 weeks for outcomes when showing effectiveness of proprioceptive exercises for sub-acromial impingement syndrome. A recent study found significant improvement for functional activity on DASH scale and pain on SPADI in proprioception group compared to conventional treatment for adhesive capsulitis, however no differences were found for range of motion and disability on SPADI in post-treatment analysis. Another study reported greater functional improvements in Maitland and Hand function exercises group, compared to Maitland group alone. However, both groups had home exercises, so the effect is unclear as evidence supports improvements for supervised exercises rather than those done at home.
In both the mentioned studies, no long-term follow up was made and patients were only treated for a period of one month. Furthermore, it is unclear what role other interventions included in the management program played in achieving the outcomes as there is no standard protocol set for adhesive capsulitis. The studies also lacked details on what type of mobilization technique to use alongside, as well as the grades of mobilizations to use. One of the studies had no blinding for treatment group allocation, while the other lacked randomization and did not calculate sample size. Both studies included patients of adhesive capsulitis in the sub-acute stage, therefore the evidence is deficient whether patients in the acute stage will benefit from proprioceptive and Hand function exercises.
Therefore, the current study aims to further explore the effect of proprioceptive and Hand function exercises in management of acute adhesive capsulitis. Incorporating these exercise interventions in the acute stage of adhesive capsulitis may result in timely resolution of the symptoms and lower the risk of progressing to later stages and developing disability. The findings of this study will help in further clearing the effectiveness so that the exercises can be made part of the routine management plan for acute adhesive capsulitis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Islamabad, Pakistan
- Riphah International Hospital
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Rawalpindi, Pakistan
- DSK Physio and Rehab
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Rawalpindi, Pakistan
- Margalla Rehab Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Painful and limited active and passive glenohumeral ROM
- Freezing or acute stage of adhesive capsulitis
- Positive Coracoid pain and DTPER tests
- Primary adhesive capsulitis/secondary due to diabetes mellitus
- Consenting to participate in the study
Exclusion Criteria:
- Bilateral adhesive capsulitis
- Sub-acute and chronic stages of adhesive capsulitis
- Unstable fractures or surgical fixation in the affected limb
- Rheumatoid arthritis
- Severe joint pain unrelieved by rest
- Osteoporosis
- Radiating pain due to cervical conditions
- Manipulations under anesthesia
- Shoulder conditions such as subacromial pain syndrome, rotator cuff tendinopathy, shoulder bursitis etc.
- Neurological damage due to stroke or Parkinsonism
- Cognitive deficits and not giving consent.
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 |
|---|---|
|
Experimental: Prioprioceptive exercises
Hot packs, mobilization, stretching and strengthening, closed and open chain kinetic exercises, hand function exercises, hand eye coordination exercises
|
Experimental group included Hot pack over shoulder region for 15 mins. Shoulder AP, PA and inferior glides (Maitland) Grade II, III, IV 30 reps x 3 sets per session, Stretching of levator scapula, upper trapezius, pectoralis major and minor with 15 second hold x 3 reps per session, Strengthening of rotator cuff muscles by manual resistance with 10 second hold x 5 reps x 2 sets per muscle per session, Plyometric CKC shoulder exercise 10 seconds each x 5 reps x 2 sets per session, CKC exercise on the ball 10 seconds each x 5 reps x 2 sets per session, Open KC exercises 10 seconds each x 5 reps x 2 sets per session, Hand-eye coordination exercises for 30 minutes/per day for 5x/per week, Hand Function Exercises for 30 minutes/per day for 5x/per week. Patients were assessed for baseline measurements against outcome measures. Patients were given a total of 10 sessions such that 5 sessions per week for the duration of 02 weeks. All patients were reassessed at the end of the 1st and 2nd week |
|
Active Comparator: Conventional
Hot packs, mobilization, stretching and strengthening, finger ladder exercise, Codman's pendulum exercise, towel stretch exercise and wand exercises
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Control group included Hot pack over shoulder region for 15 mins. Shoulder AP, PA and inferior glides (Maitland) Grade II, III, IV 30 reps x 3 sets per session, Stretching of levator scapula, upper trapezius, pectoralis major and minor with 15 second hold x 3 reps per session, Strengthening of rotator cuff muscles by manual resistance with 10 second hold x 5 reps x 2 sets per muscle per session, Finger Ladder Exercise, Codman's Pendulum Exercise, Towel Stretch Exercise and Wand Exercises 10 reps x 2 sets per session, Patients were assessed for baseline measurements against outcome measures. Patients were given a total of 10 sessions such that 5 sessions per week for the duration of 02 weeks. All patients were reassessed at the end of the 1st and 2nd week of treatment for outcome measures. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Range of motion
Time Frame: 2nd Week
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Changes from Baseline shoulder range of motion taken with the help of universal goniometer
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2nd Week
|
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Numeric Pain Rating Scale
Time Frame: 2nd Week
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Changes from Baseline pain values were taken with the help of Numeric Pain Rating Scale measures level of pain.
Scoring is done by selecting a point from zero to ten as the current level of pain.
Zero means minimum pain and 10 denotes maximum pain.
|
2nd Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Pain and Disability Index
Time Frame: 2nd Week
|
Changes from the Baseline shoulder pain and disability was taken with help of Shoulder Pain and Disability Index.
Scoring is done by separately scoring pain and disability components and adding the two and then dividing by two.
Lower scores mean low disability while higher scores show greater disability.
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2nd Week
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Disability of Arm, Shoulder and Hand
Time Frame: 2nd Week
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Changes from the Baseline problems with arm, shoulder and hand were taken with the help of Disability of Arm, Shoulder and Hand.
Scoring is done by totaling responses and dividing by total number of responses and then subtracting from one and multiplying by twenty-five.
Lower scores mean less disability and greater scores mean higher disability.
|
2nd Week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Affan Iqbal, PhD, Riphah International University, Islamabad
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCRAHS-ISB/REC/MS-PT/01871
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
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Clinical Trials on Adhesive Capsulitis
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