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NCT Number: NCT06530602

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Railway General Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location status: Recruiting

Location contact

Madiha Ali, MSOMPT

CONTACT

[email protected]

0331-3360064

Muniba Shah, MSOMPT*

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Shoulder Pain and Disability Index

    Time frame: 3rd week

    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.

  2. Measure Shoulder Range of Motion in Flexion

    Time frame: 3rd week

    changes from baseline ROM of shoulder flexion taken with goniometer

  3. Measure Shoulder Range of Motion in Extension

    Time frame: 3rd week

    changes from baseline ROM of shoulder extension taken with goniometer

  4. Measure Shoulder Range of Motion in abduction

    Time frame: 3rd week

    changes from baseline ROM of shoulder abduction taken with goniometer

  5. Measure Shoulder Range of Motion in Horizontal abduction

    Time frame: 3rd week

    changes from baseline ROM of shoulder horizontal abduction taken with goniometer

  6. Measure Shoulder Range of Motion in adduction

    Time frame: 3rd week

    changes from baseline ROM of shoulder adduction taken with goniometer

  7. Measure Shoulder Range of Motion in horizontal adduction

    Time frame: 3rd week

    changes from baseline ROM of shoulder horizontal adduction taken with goniometer

  8. Measure Shoulder Range of Motion in Internal rotation

    Time frame: 3rd week

    changes from baseline ROM of shoulder Internal rotation taken with goniometer

  9. Measure Shoulder Range of Motion in External rotation

    Time frame: 3rd week

    changes from baseline ROM of shoulder External rotation taken with goniometer

  10. Visual Analysis Scale

    Time frame: 3rd week

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

Secondary outcomes

  1. WHOQoL-BREF

    Time frame: 3rd week

    Measures perception of life quality in four dimensions including physical, psychological, social relationship & environmental.

  2. Apley's Scratch Test

    Time frame: 3rd week

    to check movements in all functional planes for the shoulder.

Study contacts

Contact information is provided by the study sponsor or research team.

Madiha Ali, MSOMPT

CONTACT

[email protected]

0331-3360064

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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