NCT03145233

Brief Summary

This pilot randomised controlled trial will directly compare the effect of isometric exercise to isotonic exercise over a period of 12 weeks for participants with a clinical diagnosis of Greater Trochanteric Pain Syndrome (GTPS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 25, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

April 25, 2017

Last Update Submit

July 18, 2018

Conditions

Gluteal Tendinitis

Keywords

physiotherapy

Outcome Measures

Primary Outcomes (1)

  • Measure of disability

    Change in score on Victorian Institute of Sport Assessment-Gluteal (VISA-G) questionnaire

    Baseline, 4 weeks and 12 weeks

Secondary Outcomes (6)

  • Quality of Life

    Baseline, 4 weeks and 12 weeks

  • Perceived change in hip pain

    Baseline, 4 weeks and 12 weeks

  • Pain intensity

    Baseline, 4 weeks and 12 weeks

  • Pain catastrophisation

    Baseline, 4 weeks and 12 weeks

  • Hip disability

    Baseline, 4 weeks and 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Isometric exercise

EXPERIMENTAL

12 week Isometric exercise programme - two exercises (one side-lying and the other standing); six repetitions of each with muscle contraction sustained for 30 seconds. Exercises performed once daily with each session lasting no longer than 10 minutes.

Other: Isometric exercise programme

Isotonic exercise

EXPERIMENTAL

12 week Isotonic exercise programme - two exercises (one side-lying and the other standing); each exercise - 3 sets of 10 repetitions, each repetition 6 seconds duration. Exercises performed once daily with each session lasting no longer than 10 minutes.

Other: Isotonic exercise programme

Interventions

Isometric exercise programmeOTHER

Exercise programme where the muscle length and joint angle do not change due to the limb being held in a static position

Isometric exercise
Isotonic exercise programmeOTHER

Exercise programme where both the muscle length and joint angle do change, consisting of concentric muscle actions (where the muscle shortens) and eccentric muscle actions (where the muscle lengthens)

Isotonic exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give written informed consent
  • Lateral hip pain for greater than 3 months
  • Pain on direct palpation of the gluteal tendon insertion on the greater trochanter and additionally at least one of the following pain provocation tests must also be positive:
  • FABER (Flexion, Abduction, External Rotation of the hip)
  • FADER (Flexion, Adduction, External Rotation of the hip)
  • FADER and resisted Internal Rotation (IR) (FADER position plus resisted IR of the hip)
  • Single leg stand for 30 seconds
  • Resisted hip abduction at end-range adduction

You may not qualify if:

  • Physiotherapy for lateral hip pain in the past 6 months
  • Corticosteroid injection for lateral hip pain in past 3 months
  • Inability to actively abduct hip in side-lying
  • Pain reproduced with FADIR (Flexion, Adduction, Internal Rotation of hip) with concurrent hip osteoarthritis on anteroposterior (AP) pelvis x-ray defined as Kellgren-Lawrence \> Grade 2 (mild)
  • Previous hip or lumbar spine surgery in past 12 months
  • Inflammatory joint disease
  • Unstable diabetes or cardiovascular disease
  • Known neurological disorders
  • Widespread chronic pain or fibromyalgia
  • Avascular necrosis
  • Pregnancy
  • Participants unable or unwilling to give informed consent
  • Participants who are unable to write, read or comprehend English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

Study Officials

  • Neal Millar, PhD FRCSEd

    University of Glasgow

    STUDY DIRECTOR

  • Lorna Paul, MPhil PhD

    Glasgow Caledonian University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2017

First Posted

May 9, 2017

Study Start

August 1, 2017

Primary Completion

July 6, 2018

Study Completion

July 6, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)