Categorized PT for Non-arthritic Hip and Groin Pain

Sponsor

Hospital for Special Surgery, New York (Other)

Overall Status

Recruiting

CT.gov ID

NCT04720846

Collaborator

(none)

Enrollment

Location

Arms

27.9

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is currently limited literature on a categorized physical therapy protocol for management of hip pain. Only a handful of studies have looked at the treatment of osteoarthritis of the hip with a standardized physical therapy treatment, primarily looking at manual therapy versus exercise therapy protocols. However, there are no studies observing the effect of a standardized physical therapy program on patients presenting with non-arthritic hip and groin pain. Based on the gap in the literature, this study will aim to assess the effect of matrix-based standard of care therapy in patients presenting with non-arthritic hip and groin pain.

Condition or Disease	Intervention/Treatment	Phase
Hip Pain Groin Pain	Other: Matrix-based physical therapy Other: Standard-of-care physical therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Assessment of a Categorized Physical Therapy Protocol for Non-arthritic Hip and Groin Pain: a Randomized Controlled Study

Actual Study Start Date :

Dec 2, 2020

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Patients will receive standard-of-care physical therapy.	Other: Standard-of-care physical therapy Physical therapy that is being conducted as standard-of-care
Experimental: Matrix-Based PT Patients will receive matrix-based physical therapy, in addition to standard-of-care physical therapy.	Other: Matrix-based physical therapy Matrix-based physical therapy will be physical therapy that is based on the matrix categorization of the patient (stiff vs. mobile hips, weak vs. strong hips) and involves instructions on the amount of time that should be spent doing stretching and strengthening therapy. Other: Standard-of-care physical therapy Physical therapy that is being conducted as standard-of-care

Arm

Intervention/Treatment

Active Comparator: Control

Patients will receive standard-of-care physical therapy.

Other: Standard-of-care physical therapy

Physical therapy that is being conducted as standard-of-care

Experimental: Matrix-Based PT

Patients will receive matrix-based physical therapy, in addition to standard-of-care physical therapy.

Other: Matrix-based physical therapy

Matrix-based physical therapy will be physical therapy that is based on the matrix categorization of the patient (stiff vs. mobile hips, weak vs. strong hips) and involves instructions on the amount of time that should be spent doing stretching and strengthening therapy.

Other: Standard-of-care physical therapy

Physical therapy that is being conducted as standard-of-care

Outcome Measures

Primary Outcome Measures

iHOT-12 (International Hip Outcome Tool-12) [Up to 6 months]
iHOT-12 is used to assess quality of life in patients with hip disorders. Scores range from 0 to 100; a higher score represents a better quality of life.

Secondary Outcome Measures

NRS (numerical rating scale) pain [Up to 6 months]
NRS pain will be used to assess pain. Scores range from 0-10, with 10 representing the worst pain imaginable.
Home exercise completion [Up to 6 months]
This will be defined as the number of times patients completed their home exercises during the previous week.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

New patient presenting with non-arthritic hip impingement, hip pain, and groin pain (Tonnis 0-1)
18-60 years old

Exclusion Criteria:

Arthritic hip pain (Tonnis 2+)
<18 and >60 years old
History of spinal fusion surgery
History of low back pain with radicular pain
History of hip arthroscopy
History of inflammatory conditions, and other concurrent problems interfering with hip therapy (i.e., concurrent back/knee/foot/ankle/shoulder issues)
Patients currently taking TNF-alpha inhibitors for inflammatory conditions
History of prior knee osteotomy
Non-English speakers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

Hospital for Special Surgery, New York

Investigators

Principal Investigator: Peter Moley, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital for Special Surgery, New York

ClinicalTrials.gov Identifier:

NCT04720846

Other Study ID Numbers:

2019-2120

First Posted:

Jan 22, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 31, 2022