Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001256864
Ethics application status
Approved
Date submitted
27/11/2012
Date registered
29/11/2012
Date last updated
29/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercises targeted at the hip to improve non-specific low back pain
Scientific title
A randomised trial to investigate the effectiveness of exercises targeted at the hip in improving non-specific low back pain
Secondary ID [1] 281590 0
Nil
Universal Trial Number (UTN)
U1111-1137-3368
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic and recurrent non specific low back pain 287871 0
Reduced hip rotation range of movement 287873 0
Condition category
Condition code
Musculoskeletal 288237 288237 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants to participate in a six week home exercise programme dependent on group randomly assigned; hip stretching, hip strengthening and hip rotation only groups.

The hip stretching and hip strengthening groups perform the rotation exercises in addition to the stretching and strengthening exercises.

Arm 1:
In the stretching group, exercises focused on a variety of stretches through a large range of hip positions aimed at stretching the entire hip capsule, ligaments and surrounding musculature (Hewitt, RRGlisson, Guilak, & Vail, 2002; Hidaka et al., 2009; Martin et al., 2008; Walker, 2007). Six stretches in addition to the two rotation exercises (eight in total) were performed. The stretches were (1) hip external rotation in crook lying, (2) hip flexion and abduction in crook lying (3) lunge hip flexor stretch (4) hip external rotation, flexion and abduction in sitting (5) standing long groin stretch and, (6) sitting short groin stretch. Stretching exercises were done once a day, 5 times a week, for six weeks. Stretches were held for 30 sec and repeated 3 times.

Arm 2:
In the strengthening group, exercises focused on strengthening the gluteus maximus, gluteus medius, gluteus minimus and short hip external rotators muscles, which were progressed throughout the intervention period. This was achieved by increasing repetitions, increasing difficulty of exercises or addition of theraband (Bolga & Uhl, 2005; Distefano, Blackburn, Marshall, & Padua, 2009; Ekstrom, Donatelli, & Carp, 2007; Snyder, Earl, O’Connor, & Ebersole, 2009). Strengthening exercises were done once a day, 3 times a week, for six weeks. Weeks one and two exercises consisted of (1) clams, (2) prone hip external rotation with theraband, (3) side-lying hip abduction, (4) quadruped hip extension, and (5) single leg stand. Weeks three and four exercises consisted of (1) quadruped hip extension, (2) quadruped hip abduction/ external rotation, (3) single leg bridge, (4) single leg squats, (5) lateral step exercise, and (6) standing hip rotation exercise. Weeks five and six exercises consisted of (1) quadruped hip extension, (2) quadruped hip abduction/ external rotation, (3) single leg squats, (4) single leg bridge, (5) lateral step exercise, and (6) standing hip rotation exercise with theraband. Exercises were performed 10 to 15 reps, 2 to 3 sets.
Intervention code [1] 286117 0
Treatment: Other
Comparator / control treatment
The hip rotation only group performs only hip rotation exercises once a day, 5 times a week, for six weeks. Each exercise was held for 30 sec and repeated 3 times.
The exercise consisted of active hip internal rotation and external rotation stretching in prone with participants instructed to perform movement without moving their pelvis or back.
Control group
Active

Outcomes
Primary outcome [1] 288427 0
Numerical rating scale for pain
Timepoint [1] 288427 0
Outcome measures taken at baseline and then six weeks following the home exercise intervention programme.
Primary outcome [2] 288429 0
modified oswestry questionnaire for function
Timepoint [2] 288429 0
Outcome measures taken at baseline and then six weeks following the home exercise intervention programme.
Secondary outcome [1] 300131 0
hip rotation range of movement measured passively in prone using a standard goniometer.
Timepoint [1] 300131 0
Outcome measures taken at baseline and then six weeks following the home exercise intervention programme.

Eligibility
Key inclusion criteria
Inclusion criteria for this study were people with non-specific chronic or recurrent low back pain with reduced hip rotation range of movement. Chronic low back pain was defined as symptoms present on greater than half the days in a 12-month period, occurring in a single or in a multiple episodes (Von Korff, 1994). Recurrent low back pain was defined as symptoms present on less than half of the days in a 12-month period, occurring in multiple episodes over the year (Von Korff, 1994).

Hip rotation range of movement was measured passively in prone using a standard goniometer.
Passive rotation range of movement was assessed to eliminate lumbopelvic movement that may occur with active hip rotation (Gombatto, Collins, Sahrmann, Engsberg, & Van Dillen, 2006). Reduced hip rotation range of movement was either reduced internal rotation or external rotation (<30º) (Burns, et al., 2011).
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People were excluded if they reported a history of spinal infections, spinal surgery, rheumatologic disorders, marked spinal deformity, lower extremity impairment, osteoporosis, severe neurological involvement, cancer, or were currently pregnant.

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)
Participants were recruited through an article in the local newspaper and advertisement posters at local businesses and sports clubs.

Participants who were eligible were randomly assigned to 1 of 3 exercise groups by choosing a number from an opaque envelope. The groups were (1) hip stretching, (2) hip strengthening, or (3) hip rotation only.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants assessed for eligibility; excluded due to not meeting inclusion criteria or decline to participate; randomly assigned by choosing a number from an opaque envelope into one of 3 exercise groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286395 0
Self funded/Unfunded
Name [1] 286395 0
Sara Winter
Country [1] 286395 0
Australia
Primary sponsor type
Individual
Name
Sara Winter
Address
30 Soule Street
Hermit Park
Townsville
Queensland 4812
Country
Australia
Secondary sponsor category [1] 285179 0
None
Name [1] 285179 0
Address [1] 285179 0
Country [1] 285179 0
Other collaborator category [1] 277201 0
Other
Name [1] 277201 0
Polly McGuigan
Address [1] 277201 0
Department for Health
University of Bath
Claverton Down
Bath
England
BA2 7AY
Country [1] 277201 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288458 0
Research Ethics Approval Committee for Health of the University of Bath, England.
Ethics committee address [1] 288458 0
Ethics committee country [1] 288458 0
United Kingdom
Date submitted for ethics approval [1] 288458 0
22/06/2011
Approval date [1] 288458 0
13/07/2011
Ethics approval number [1] 288458 0
Was not given one.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34985 0
Address 34985 0
Country 34985 0
Phone 34985 0
Fax 34985 0
Email 34985 0
Contact person for public queries
Name 18232 0
Sara Winter
Address 18232 0
30 Soule Street
Hermit Park
Townsville
Queensland
4812
Country 18232 0
Australia
Phone 18232 0
+61 (0) 400970342
Fax 18232 0
Email 18232 0
[email protected]
Contact person for scientific queries
Name 9160 0
Sara Winter
Address 9160 0
30 Soule Street
Hermit Park
Townsville
Queensland
4812
Country 9160 0
Australia
Phone 9160 0
+61 (0) 400970342
Fax 9160 0
Email 9160 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of targeted home-based hip exercises in individuals with non-specific chronic or recurrent low back pain with reduced hip mobility: A randomised trial.2015https://dx.doi.org/10.3233/BMR-150589
N.B. These documents automatically identified may not have been verified by the study sponsor.