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

NCT06530602 | Recruiting

• 1 other identifier: Muniba
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Frozen Shoulder

Keywords

Frozen shoulder; QOL; Clinical trail; 3 D SPA; SPADI

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• Visual Analysis Scale

  Maximum score 10 minimum score 0 , it is used for both acute and chronic pain.

  3rd week

Secondary Outcomes (2)

• WHOQoL-BREF

  3rd week

• Apley's Scratch Test

  3rd week

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

ACTIVE COMPARATOR

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)

Interventions

3 D SPA (shoulder complex pain alignment) Moblization OTHER

3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.

Group A

Shoulder Moblization (KaltenBorn) OTHER

3 per week, mobilization for 5 mins and 30 min session for total 3 weeks , exercises 3 sets for 10 repetitions.

Group B

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Madiha Ali, MSOMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madiha Ali, MSOMPT

CONTACT

0331-3360064; madiha.ali@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: August 9, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 10, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)