3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.

Effect of 3-Dimensional Shoulder Complex Pain Alignment (3-D SPA) Mobilization on Frozen Shoulder.

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.

Study Overview

• Status: Recruiting
• Conditions: Frozen Shoulder
• Intervention / Treatment: Other: 3 D SPA (shoulder complex pain alignment) Moblization; Other: Shoulder Moblization (KaltenBorn)

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madiha Ali, MSOMPT; Phone Number: 0331-3360064; Email: madiha.ali@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 44000
      • Recruiting
      • Railway General Hospital
      • Contact: Madiha Ali, MSOMPT; Phone Number: 0331-3360064; Email: madiha.ali@riphah.edu.pk
      • Principal Investigator: Muniba Shah, MSOMPT*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 3-D SPA (shoulder complex pain alignment) Moblization. Conventional therapy & Home Plan Treatment session: 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions. Modality: Ultrasound Mode: continuous 3 MHz, 1.5 w/cm2 for 6 min	Other: 3 D SPA (shoulder complex pain alignment) Moblization; 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.
Active Comparator: Group B; Shoulder mobilization (kaltenborn) Conventional therapy & Home Plan Treatment session: 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions. Modality: Ultrasound Mode: continuous 3 MHz, 1.5 w/cm2 for 6 min	Other: Shoulder Moblization (KaltenBorn); 3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure Shoulder Range of Motion in Flexion	changes from baseline ROM of shoulder flexion taken with goniometer	3rd week
Measure Shoulder Range of Motion in Extension	changes from baseline ROM of shoulder extension taken with goniometer	3rd week
Measure Shoulder Range of Motion in abduction	changes from baseline ROM of shoulder abduction taken with goniometer	3rd week
Measure Shoulder Range of Motion in Horizontal abduction	changes from baseline ROM of shoulder horizontal abduction taken with goniometer	3rd week
Measure Shoulder Range of Motion in adduction	changes from baseline ROM of shoulder adduction taken with goniometer	3rd week
Measure Shoulder Range of Motion in horizontal adduction	changes from baseline ROM of shoulder horizontal adduction taken with goniometer	3rd week
Measure Shoulder Range of Motion in Internal rotation	changes from baseline ROM of shoulder Internal rotation taken with goniometer	3rd week
Measure Shoulder Range of Motion in External rotation	changes from baseline ROM of shoulder External rotation taken with goniometer	3rd week
Shoulder Pain and Disability Index	Questionnaire comprise of 13 items evaluates both the degree of pain and the level of challenge in performing activities of daily living (ADLs) that involve the use of the upper extremities. The pain subscale comprises 5 items, while the Disability subscale consists of 8 items.	3rd week
Visual Analysis Scale	Maximum score 10 minimum score 0 , it is used for both acute and chronic pain.	3rd week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WHOQoL-BREF	Measures perception of life quality in four dimensions including physical, psychological, social relationship & environmental.	3rd week
Apley's Scratch Test	to check movements in all functional planes for the shoulder.	3rd week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Madiha Ali, MSOMPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): January 10, 2025

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: July 28, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: QOL; SPADI; Frozen shoulder; Clinical trail; 3 D SPA
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: Muniba

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No