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Trial registered on ANZCTR


Registration number
ACTRN12614000534684
Ethics application status
Approved
Date submitted
14/05/2014
Date registered
20/05/2014
Date last updated
20/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low Back Pain and Stretching Exercise
Scientific title
The Effect of Stretching Hamstring, Gastrocnemius, Iliopsoas and Back Muscles on Pain and Functional Activities in Patients with Chronic Low Back Pain: A Randomized Clinical Trial
Secondary ID [1] 284584 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 291874 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292224 292224 0 0
Physiotherapy
Musculoskeletal 292225 292225 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All subjects attended the physical therapy sessions three times per week for six weeks. Experimental group performed manual passive stretching exercises for hamstring, gastrocnemus, hamstring and back muscles. The patient sits on long sitting position with knees fully extended and the feet together in dorsiflextion and against the wall to stretch the gastrocnemius muscle. We asked the patient to bend forward from the hips to reach towards the feet with the head in flexion. The physical therapists came behind the patient and push him/her forward to stabilize the patient’s position and knees and hold the position for 30 seconds, then relax for 30 seconds, with three repetitions per set, three sets per visit and three visits per week for a period of six weeks.
Subjects also performed stretching exercise for iliopsoas muscle. The patient lies on a crock lying position with both lower limbs hanging out of the end of the table holding one knee to the chest, the therapist is in front of both lower limbs and one hand holds the flexed knee while the other hand stretches the other leg by pushing down and hold the position for 30 seconds, then relax for 30 seconds with three repetitions per set, three sets per visit and three visits per week for a period of six weeks.
Strengthening exercises were performed in both groups. Performing sitting up from a supine position with hips and knees flexed used for abdominal muscles strengthening exercises. Head and shoulders are lifted with a gradual curl to touch the knees with the hands. The abdominal muscle becomes more efficient. Thus isotonic abdominal exercise should begin with the hips and knees flexed. A strengthening exercise program for abdominal muscles performed ten repetitions, ten seconds hold and ten to 15 seconds relax for ten sets per visit and three visits per week for a period of six weeks.
Stretching and strengthening exercises were undertaken during 3 x 1 hour sessions per week for a period of 6 weeks. Participants in both groups received health education for low back pain by researchers including correct posture and appropriate behavior changes to enhance functional outcomes
Intervention code [1] 289359 0
Rehabilitation
Comparator / control treatment
In the control group, patients performed manual passive stretching exercises for hamstring and back muscles. The patient sits on long sitting position with knees fully extended and the feet together free or on planter flexion. We asked the patient to bend forward from the hips to reach towards the feet with the head in flexion. The physical therapists came behind the patient and push him/her forward to stabilize the patient’s position and knees and hold the position for 30 seconds, then relax for 30 seconds, with three repetitions per set, three sets per visit and three visits per week for a period of six weeks.
Subjects also performed stretching exercise for iliopsoas muscle. The patient lies on a crock lying position with both lower limbs hanging out of the end of the table holding one knee to the chest, the therapist is in front of both lower limbs and one hand holds the flexed knee while the other hand stretches the other leg by pushing down and hold the position for 30 seconds, then relax for 30 seconds with three repetitions per set, three sets per visit and three visits per week for a period of six weeks.
Strengthening exercises were performed in both groups. Performing sitting up from a supine position with hips and knees flexed used for abdominal muscles strengthening exercises. Head and shoulders are lifted with a gradual curl to touch the knees with the hands. The abdominal muscle becomes more efficient. Thus isotonic abdominal exercise should begin with the hips and knees flexed. A strengthening exercise program for abdominal muscles performed ten repetitions, ten seconds, hold and ten to 15 seconds, relax for ten sets per visit and three visits per week for a period of six weeks.
Stretching and strengthening exercises were undertaken during 3 x 1 hour sessions per week for a period of 6 weeks. Participants in both groups received health education for low back pain by researchers including correct posture and appropriate behavior changes to enhance functional outcomes
Control group
Active

Outcomes
Primary outcome [1] 292095 0
The primary outcome measurement was pain on visual analogue scale (VAS). It ranges from zero (no pain) to ten (unbearable pain) grades, from 1 to 10 means graduation intensities of pain. The subjects were asked to indicate the level of lower back pain by placing a dash at the appropriate level on the 10 cm horizontal line. The subjects were provided with an Arabic version of VAS with no pain on the right side and worst pain on the left side.
Timepoint [1] 292095 0
Outcome measurements were taken at baseline and the end of week six after the study was begun.
Secondary outcome [1] 308199 0
The secondary outcomes were Modified fingertip-to-floor test for measuring the range of motion of lumbar flexion. The distance between the tip of the middle finger and the floor is usually measured with a tape measure to measure changes in lumbar flexion of patients with LBP. Also, a stool with height 19 cm has been used for subjects to stand on in order to measure the ROM. The measurements are taken with the modified fingertip-to- floor method by having the patient forward bend while standing on a stool in an attempt to touch the floor with the fingertips and then measuring the distance between the tip of the middle finger and the top of the stool
Timepoint [1] 308199 0
The outcome measurements were taken at baseline and at the end of week six after the study was begun.
Secondary outcome [2] 308200 0
The secondary outcome is Oswestry questionnaire disability for LBP, which is a Low back pain disability questionnaire.
Timepoint [2] 308200 0
Outcome measurements were taken at the baseline and the end of week six after the study was begun.
Secondary outcome [3] 308201 0
The secondary outcome measurement was Lateral view of loading x-ray, which is used to detect any change in the lordotic curve by measuring lumbo-sacral (LS) angle.
Timepoint [3] 308201 0
The outcome measurements were taken at the baseline and the end of week six after the study begun.

Eligibility
Key inclusion criteria
The inclusion criteria were patient’s diagnosis of low back pain and complaint of pain for more than three months.
Minimum age
25 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any pathological involvement such as disc herniation, tumor, cancer, spinal stenosis, vertebral fracture or neurological deficits.

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)
The patients were randomly assigned into two groups by drawing of forty identical envelopes that are labeled A (control group) and B (experimental group)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by creating randomization table using a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6048 0
Egypt
State/province [1] 6048 0
Cairo

Funding & Sponsors
Funding source category [1] 289221 0
Self funded/Unfunded
Name [1] 289221 0
Aqeel M Alenazi
Address [1] 289221 0
Physical Therapy and Rehabilitation Department, College of Applied Medical Sciences, Salman Bin Abdulaziz University, AlKharj, Saudi Arabia. PO BOX. 422 Alkharj 11942
Country [1] 289221 0
Saudi Arabia
Primary sponsor type
Individual
Name
Ashraf Ramadan Hafez
Address
23 Kasr Al Ainy street, Cairo University Hospital, Cairo, Egypt.
Post code: 11562

Country
Egypt
Secondary sponsor category [1] 287922 0
Individual
Name [1] 287922 0
Aqeel M Alenazi
Address [1] 287922 0
Physical Therapy and Rehabilitation Department, College of Applied Medical Sciences, Salman Bin Abdulaziz University, AlKharj, Saudi Arabia. PO BOX. 422 Alkharj 11942
Country [1] 287922 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290998 0
Ethical Review Board at Cairo University Hospital
Ethics committee address [1] 290998 0
23 Kasr Al Ainy street, Cairo University Hospital, Cairo, Egypt.
Post code: 11562
Ethics committee country [1] 290998 0
Egypt
Date submitted for ethics approval [1] 290998 0
04/07/2013
Approval date [1] 290998 0
15/07/2013
Ethics approval number [1] 290998 0
27024/1434

Summary
Brief summary
The aim of this study was to compare the clinical outcomes between two different exercise programs for the management of patients with chronic low back pain. We hypothesized that individuals treating by a program, which includes stretching exercises for back, hamstring and iliopsoas and gastrocnemius muscles followed by strengthening exercises for abdominal muscle and functional activities postural instructions, would achieve better outcomes compared with individuals receiving another program, which includes stretching exercises for back, hamstring and iliopsoas without gastrocnemius muscles stretching followed by strengthening exercises for abdominal muscle and activities of daily living postural instructions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48306 0
Mr Aqeel M Alenazi
Address 48306 0
Physical Therapy and Rehabilitation Department, College of Applied Medical Sciences, Salman Bin Abdulaziz University, AlKharj City, KSA
P.O 422 Alkharj 11942
Country 48306 0
Saudi Arabia
Phone 48306 0
+966501677557
Fax 48306 0
Email 48306 0
aqeeel_86@hotmail.com
Contact person for public queries
Name 48307 0
Prof Ashraf R Hafez
Address 48307 0
23 Kasr Al Ainy street, Cairo University Hospital, Cairo, Egypt.
Post code: 11562
Country 48307 0
Egypt
Phone 48307 0
+201116915026
Fax 48307 0
Email 48307 0
ashrafrh1989@yahoo.com
Contact person for scientific queries
Name 48308 0
Prof Ashraf R Hafez
Address 48308 0
23 Kasr Al Ainy street, Cairo University Hospital, Cairo, Egypt.
Post code: 11562
Country 48308 0
Egypt
Phone 48308 0
+201116915026
Fax 48308 0
Email 48308 0
ashrafrh1989@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary