Categorized PT for Non-arthritic Hip and Groin Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Groin Pain; Hip Pain
• Intervention / Treatment: Other: Standard-of-care physical therapy; Other: Matrix-based physical therapy

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Cheng; Phone Number: 6467146870; Email: chengj@hss.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital For Special Surgery
      • Contact: Jennifer Cheng; Email: chengj@hss.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Standard-of-care physical therapy; Physical therapy that is being conducted as standard-of-care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iHOT-12 (International Hip Outcome Tool-12)	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.	Up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2019-2120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No