Clinical trial NCT06530602: 3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.
Official title: Effect of 3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frozen Shoulder
Keywords: Frozen shoulder
QOL
Clinical trail
3 D SPA
SPADI
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ongoing research aims to assess the enhancement of shoulder mobility by specifically addressing restrictions in all three planes of movement. current studies seek to investigate the impact of three-dimensional mobilization technique on their recovery and to prevent progression of disease to reduce pain, alleviate muscle tightness, facilitate tissue healing, and ultimately improve the range of motion in patients. A randomized control trial that will include total 36 participants. The first group will receive 3 Dimensional shoulder pain alignment (3-D SPA) mobilization along with conventional therapy and 2nd group will receive Shoulder mobilization along with conventional therapy. Data collected will be analyzed through SPSS 27.

Detailed description: Decrease capacity of non contractile tissue ( such as joint capsule ) inflammation of capsule and ligament adhesion affects the shoulder joint, triggering stiffness and pain in Frozen shoulder. About 2% to 5% of the general population reported frozen shoulder without well known cause defined ,out of which Female patients 35 - 65 years of age.

hindrance in quality of life reported with performance of basic activities of daily living due to pain that worsen with movement and specifically at night , stiffness that cause mobility deficit.70% of female population are prone to get frozen shoulder. When reaching overhead, the arm is lifted by movements in the sternoclavicular , acromioclavicular (AC), scapulothoracic (ST), and gleno-humeral joints while overhead activities got limited in frozen shoulder.

Abnormal glenohumeral rhythm at scapulothoracic joint by posterior tilting of scapula and early upward motion of scapula occur. hence a capsular pattern developed in patient that comprise of External rotation, Abduction and Internal rotation.

Physiotherapy encompassed variety of treatment protocols for frozen shoulder including therapeutic modalities and manual therapy technique's consisting moblization, muscle energy techniques ,spencer's technique ,PNF and some of invasive treatments dry needling and therapeutic exercises.

3 D SPA is latest technique with no literature available for this to be applied to check its effectiveness on frozen shoulder rather it merely applied for post stroke shoulder pain prior in clinical setting . In group A 3-D SPA Moblization is employed that target moblization of AC joint (mobilizing it upward posteriorly) synchronously Scapula mobilized (abduction-adduction, anterior-posterior tilting) with glenohumeral Active motion in (flexion, horizontal abduction, horizontal adduction \& External Internal rotation) all at once in all 3 planes frontal, sagittal, transverse plane while kaltenborn mobilization in anterior, posterior and inferior direction that is employed in group B, that has been a treatment of choice over the time is effective to treat frozen shoulder.

the study aim to evaluate the effect of 3-Dimensional Shoulder complex Pain Alignment (3-D SPA) mobilization technique on pain, disability, Range of Motion and quality of life.

Eligibility criteria: Inclusion Criteria:

* Local shoulder pain, often present either above the antero-medial and Lateral aspect of the shoulder.
* Stage II\& III unilateral frozen shoulder Symptoms.
* Marked loss Of AROM \& PROM with at least 50%loss of external rotation.
* Positive Apley's Scratch test.

Exclusion Criteria:

* Radiculopathy.
* Thoracic-outlet syndrome.
* Fractures and tumors of the upper extremity.
* Neurological disorders causing muscle weakness in the shoulder.
* Corticosteroid injection for frozen shoulder in last 3 months.

Primary outcomes:
measure: Shoulder Pain and Disability Index
timeFrame: 3rd week
measure: Measure Shoulder Range of Motion in Flexion
timeFrame: 3rd week
measure: Measure Shoulder Range of Motion in Extension
timeFrame: 3rd week
measure: Measure Shoulder Range of Motion in abduction
timeFrame: 3rd week
measure: Measure Shoulder Range of Motion in Horizontal abduction
timeFrame: 3rd week
measure: Measure Shoulder Range of Motion in adduction
timeFrame: 3rd week
measure: Measure Shoulder Range of Motion in horizontal adduction
timeFrame: 3rd week
measure: Measure Shoulder Range of Motion in Internal rotation
timeFrame: 3rd week
measure: Measure Shoulder Range of Motion in External rotation
timeFrame: 3rd week
measure: Visual Analysis Scale
timeFrame: 3rd week
Secondary outcomes:
measure: WHOQoL-BREF
timeFrame: 3rd week
measure: Apley's Scratch Test
timeFrame: 3rd week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Madiha Ali, MSOMPT
role: PRINCIPAL_INVESTIGATOR
References: