NCT06668415

Brief Summary

Adhesive Capsulitis is a common Musculoskeletal disorder characterized by pain and progressive joint restriction in capsular pattern. Adhesive capsulitis can be managed by both conservative and non conservative treatment. The Spencer technique and hydrodilation are two treatment approaches used to restore range of motion in adhesive capsulitis. The Spencer technique is a form of physical therapy that involves joint mobilizations and manual stretching exercises. It aims to improve shoulder mobility and reduce pain by addressing the tightness and stiffness in the shoulder capsule and surrounding tissues. Hydrodilation, on the other hand, is a procedure where a saline solution is injected into the shoulder joint to distend the capsule. This distention helps stretch the tight tissues and break up adhesions, facilitating improved range of motion.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 30, 2024

Last Update Submit

October 30, 2024

Conditions

Keywords

Hydrodilation, spencer technique, pain, functional disability, range of motion

Outcome Measures

Primary Outcomes (2)

  • Shoulder ROM

    Range of Motion will be measured using the universal Goniometer which is 0 to 180 degree for half circle model or 0 to 360 degree for full circle models.

    4 weeks

  • Pain Intensity

    Pain will be assessed using Visual Analog scale which is 0-100 item scale.

    04 Weeks

Secondary Outcomes (1)

  • Shoulder Disability

    4 weeks

Study Arms (2)

Group A (Hydrodilation+Spencer Technique )

ACTIVE COMPARATOR

Patients in this group will be followed by Spencer Technique after Hydrodilation for the duration of 4 weeks which includes 12 sessions in total. Spencer muscle energy technique is a seven 7 step procedure which consists of shoulder extension with elbow flexed, shoulder flexion with elbow flexed, circumduction with compression, circumduction with traction, Abduction then adduction with external rotation and glenohumeral pump. Following the complete action, patients will be encouraged to use their muscles for 3 to 5 seconds against little resistance provided by the therapist

Procedure: Hydro dilationProcedure: Spencer muscle energy technique

Group B (Hydro dilation+ Passive Stretching)

EXPERIMENTAL

This group will undergo Passive Stretching followed by Hydrodilation. The low intensity stretches will be given in supine for all the movements ie Flexion ,Abduction , Internal Rotation and External Rotation for 5 repititions with 30 sec hold. (7)

Procedure: Hydro dilationProcedure: Passive Stretching

Interventions

The hydro dilation injections comprises of Depomedrol 80mg and normal saline 0.9%. It is performed under fluoroscopic guidance by the orthopedic surgeon.

Group A (Hydrodilation+Spencer Technique )Group B (Hydro dilation+ Passive Stretching)

Spencer muscle energy technique is a seven 7 step procedure which consists of shoulder extension with elbow flexed, shoulder flexion with elbow flexed, circumduction with compression, circumduction with traction, Abduction then adduction with external rotation and glenohumeral pump. Following the complete action, patients will be encouraged to use their muscles for 3 to 5 seconds against little resistance provided by the therapist

Group A (Hydrodilation+Spencer Technique )

The low intensity stretches will be given in supine for all the movements ie Flexion ,Abduction , Internal Rotation and External Rotation for 5 repititions with 30 sec hold.

Group B (Hydro dilation+ Passive Stretching)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosed unilateral Adhesive Capsulitis and have undergone Hydrodilation. --Includes both genders

You may not qualify if:

  • Population who have recently undergone major shoulder injury or surgery, had fracture or open wound or there is reduction of Glen humeral ROM due to any other cause other than Adhesive Capsulitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

BursitisPain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Javeria Ilyas, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups. Both groups; Group A and B will undergo Hydrodilation but Group A will be followed by Spencer Technique whereas Group B will be followed by Passive Stretching.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2024

First Posted

October 31, 2024

Study Start

July 20, 2024

Primary Completion

October 1, 2024

Study Completion

October 31, 2024

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations