Comparison of Spencer Technique and Conventional Treatmen... | NCT06739824

Studies
Comparison of Spencer Technique and Conventional Treatment in Adjuncts to Corticosteroid Injection in Frozen Shoulder

NCT06739824

Sponsor

Superior University

Status

Active, not recruiting

Last Update Posted

Dec 18, 2024Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Frozen Shoulder

Interventions

Conventional Treatment(CI)
Spencer Technique (CI)

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2024Actual

Primary Completion Date

Aug 1, 2024Actual

Completion Date

Jan 31, 2025Estimated

First Submitted Date

Dec 14, 2024

First Submission Date that Met QC Criteria

Dec 14, 2024

First Posted Date

Dec 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2024

Last Update Posted Date

Dec 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will compare the effectiveness of the Spencer Technique combined with intra-articular injection versus conventional therapy combined with intra-articular injection in managing frozen shoulder. The research problem addresses the need for optimal therapeutic approaches to improve pain relief, range of motion, and functional recovery in patients with frozen shoulder.

Detailed Description

Utilizing a randomized controlled trial, the study will recruit 100 participants, divided into two groups: Group A receiving the Spencer Technique with intra-articular injection and Group B receiving conventional therapy with intra-articular injection. Outcome measures will include pain levels, range of motion, shoulder functional status and patient satisfaction, assessed through validated tools. The significance of this study lies in its potential to provide robust comparative data to guide clinical decisions and enhance patient outcomes, particularly in populations with a high prevalence of diabetes

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	Experimental		Diagnostic Test: Conventional Treatment(CI)
EXP group	Active Comparator		Combination Product: Spencer Technique (CI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conventional Treatment(CI)	Diagnostic Test	Patients receive a corticosteroid injection followed by conventional treatment, such as standard physical therapy exercises focused on range of motion and strengthening, without the specific manual techniques of the Spencer method.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional Shoulder Scale	This tool includes a pain scale with a score of 1 to 10 and daily activity scales, including 10 activities. Each activity has a score of 1 to 10.	12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

30 years 60 years old.
Diagnosed with unilateral adhesive capsulitis presenting symptoms of pain.
restricted range of motion of frozen shoulder Stage 2 and 3

Exclusion Criteria:

Rotator cuff injury
Long-term Systemic Corticosteroid use
Previous Ipsilateral shoulder CSI within 12 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Haider Hospital/THQ Muridke		Sheikhupura	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002062	Bursitis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided