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Trial registered on ANZCTR

Registration number

ACTRN12617001611314

Ethics application status

Approved

Date submitted

8/11/2017

Date registered

8/12/2017

Date last updated

21/01/2020

Date data sharing statement initially provided

21/01/2020

Date results provided

21/01/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

D-tape for hip pain, does it work?

Scientific title

Comparative Sports Taping for Pain Relief and Gait Correction in Women with Greater Trochanteric Pain Syndrome

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1189-2604

Trial acronym

D'Tape

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Gluteal tendinopathy

Hip bursitis

Lateral hip pain

Greater trochanteric pain syndrome

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a non-drug trial. Participants will have Dynamic tape (TM) - a form of elastic sports tape, applied to the side of their painful hip. The tape will be applied by a final year physiotherapy student specifically trained to do this, under the supervision of a physiotherapist with 30 yrs experience, and three degrees.
The tape will be applied twice in the same day using an identical pattern, but with a difference in stretch application. The order of application will be randomly assigned.
One application will be with no stretch applied, and the alternative application is with the recommended amount of stretch of 25% applied.
The first application will follow the base line gait assessment, and will be in place for about 20 minutes while the participant undertakes a second gait assessment. The second application will follow a washout period. The washout period is 25 minutes in duration and includes ascending and descending 25 steps. The participant will then immediately undertake a third gait assessment. The participant will then leave the second application on for up to 7 days. (Please see below)
Immediately after each tape application, the participant will be asked to walk approximately 300m. During walking their movement will be captured using a VICOM motion capture system.
Following the second tape application and gait assessment the participant will be invited to leave the tape in place for up to one week. At the end of that week the student will call the participant to ask for an average pain rating.
The study will be conducted in a university health research setting.

After each application, the participant will be asked to walk approximately 300m. During walking their movement will be captured using a VICOM motion capture system.

The final application of tape will be left on for one week. At the end of that week the student will call the participant to ask for an average pain rating.
The study will be conducted in a university health research setting.

Adherence to tape application will be monitored during the gait assessment. At the end of the follow up period the student will ask the participant how long they left the tape in place for.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Participants will act as their own controls. They will walk once to establish a base line, and one trial with the tape on in an unstretched manner, and the second trial with the tape applied as per the manufacturers' instructions. The three walking trials will be compared with each other.

The tape application without stretch is considered a placebo intervention.

Control group

Placebo

Outcomes

Primary outcome [1]

Adduction moment during normal gait at a brisk self-selected speed via the Vicon motion capture system.

The Vicon motion capture system measures joint movement via light reflective markers attached to pre-determined anatomy on a person, and cameras. The gait laboratory has a force plate in the floor. By combining the information from the light reflective markers and the force plate, hip adduction moment can be calculated.

Timepoint [1]

The primary outcome will be collected on one day, with three time points within a one hour window.
1. Base line walking - with not tape applied
2. Walking with trial one tape
3. Walking with trial two tape

Secondary outcome [1]

Pain, as measured by numeric rating scale (NRS)

Timepoint [1]

Pain data will be collected on the day of gait assessment: Prior to the baseline walking assessment (no tape applied), immediately following each of the trail of tape application, and once one week post gait assessment

Secondary outcome [2]

VISA-G score
This is a severity score specially designed for people with hip tendon pain.

Timepoint [2]

This will be assessed prior to any gait assessment.

Secondary outcome [3]

The "Assessment of quality of life" (AQoL6D) is avalidated standardised self assessment tool to evaluate an individual's quality of life.

https://www.aqol.com.au/

Timepoint [3]

This will be assessed prior to any gait assessment.

Eligibility

Key inclusion criteria

Minimum 3 month history of greater trochanteric pain syndrome (pain on the lateral side of the hip, pain on palpation of the greater trochanter).
A average pain score of greater then 2 on an 11 point scale on most days for the preceding week.
Pain on the lateral side of the hip, pain on palpation of the greater trochanter and a positive result to one or more of the FABER (flexion, abduction, external rotation) test, the single leg stance test or the resisted FADER (flexion, adduction, external rotation) test.

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Low back pain of more then 2 on an 11 point scale on most days for the preceding week.
Pain referral pattern continuous from the lumbar spine into the buttocks, thigh or leg.
Lumbar radiculopathy
Systemic inflammatory disease
Neurological disease, e.g. Parkinson's disease
Bone cancer
People who are unable to provide informed consent in English.
Groin pain reproduction with medial rotation or the FABER test
If the ultrasound finds no evidence of gluteal tendinopathy.
Anyone allergic to sports tape.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

All participants will act as their own control. The order of tape application will be determined by a toss of the coin by researcher AF. The result of the coin toss will known only to the person applying the tape.

The allocation will be done on the day of testing, thus recruitment into the study and allocation is concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Toss of the coin

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Participants will act as their own controls. With participants walking once to establish a base line, once with tape applied with no stretch, and once with tape applied with industry recommended stretch.
The tape applied in a non-stretch manner will act as a sham treatment. The order of the application of the tape will be randomised.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Gait analysis changes will be analysed using a repeated measures ANOVA.
Pain level post gait analysis will be analysed using a student t-test.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

9/01/2017

Date of last participant enrolment

Anticipated

Actual

24/04/2017

Date of last data collection

Anticipated

Actual

1/05/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Industry support from Dynamic Tape

Address [1]

Building 12, level D, room 41
Discipline of Physiotherapy
University of Canberra
University Drive
Bruce 2606, ACT

Country [1]

Australia

Primary sponsor type

University

Name

University of Canberra

Address

University Drive,
Bruce, 2606, ACT

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Canberra Human Research Ethics Committee

Ethics committee address [1]



Research Student Office Administration
Building 26
27 Thynne St, Bruce
University of Canberra, ACT, 2601

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/10/2016

Approval date [1]

11/11/2016

Ethics approval number [1]

16-232

Summary

Brief summary

Hip pain is a common condition that results in a reduction of activity, reduced work participation and reduced quality of life. Greater trochanteric pain syndrome (GTPS), considered to be primarily due to gluteal tendinopathy, is a common cause of hip pain in women over the age of 45. Women with GTPS have been shown to have an altered gait which is thought to aggravate, if not perpetuate, the pathology. Cortsone injection is the most common form of treatment for this condition, however, cortisone can cause tissue damage and is frequently associated with poor long term results. We need an alternative to cortisone that will provide pain relief without the long term negative consequences. We plan to undertake a study to test if flexible Dynamic sports tape is able to correct the gait changes seen in this population, and if it can reduce the associated pain reported by people with GTPS. 35 women with a 3 month history of GTPS will be recruited. Their gait will be evaluated via VICOM motion analysis system under three conditions: 1) base line gait, 2) Dyanamic tape applied with a 30% stretch, and 3) Dynamic tape applied without stretch. The latter two will be undertaken in random order. The final application of tape will be left on the participant for one week. One of the researchers will call the participants at the end of the week to ask them to report the level of their hip pain. 
The main outcome measurement is the amount of hip movement towards the midline – during the standing phase of gait. This is measured in Nm/WB.Ht. We will assess if the Dynamic tape can change this in women with GTPS. The second outcome measure is pain. We will measure this via a verbal rating score of 0 to 10, with 0 being no pain, and 10 being the worst pain imaginable.  Women will be asked to rate their pain prior to walking, during each trial, and one week post walking.

Trial website

Trial related presentations / publications

Public notes

People with hip bursitis or greater trochanteric pain syndrome report pain on the outside of their hip. They have difficulty with sleeping on their side, walking and general activities that require their legs. 

It is now thought that these conditions are caused by gluteal tendon problems. 
This can cause people to have difficulty with walking, or to walk with a limp.

Contacts

Principal investigator

Name

Dr Angie fearon

Address

Building 12, Level D, Room 41
Discipline of Physiotherapy
Faculty of Health
University of Canberra,
University Drive,
Bruce, ACT, 2606

Country

Australia

Phone

+61 2 6206 8717

Fax

[email protected]

Contact person for public queries

Name

Angie Fearon

Address

Building 12, Level D, Room 41
Discipline of Physiotherapy
Faculty of Health
University of Canberra,
University Drive,
Bruce, ACT, 2606

Country

Australia

Phone

+61 2 6206 8717

Fax

[email protected]

Contact person for scientific queries

Name

Angie Fearon

Address

Building 12, Level D, Room 41
Discipline of Physiotherapy
Faculty of Health
University of Canberra,
University Drive,
Bruce, ACT, 2606

Country

Australia

Phone

+61 2 62068717

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Does Dynamic Tape change the walking biomechanics of women with greater trochanteric pain syndrome? A blinded randomised controlled crossover trial.	2019	https://dx.doi.org/10.1016/j.gaitpost.2019.02.031

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically