Protocol summary
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Study aim
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The study aims to find out the effects of Voodoo floss band with Proprioception neuromuscular facilitation(Hold-Relax) stretching in improving Hamstring Flexibility and pain reduction in low back and lumbar flexion ROM in patients with Non-specific Chronic low back pain.
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Design
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Quasi-Experimental study
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Settings and conduct
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Clinics and Hospitals will be the settings and the research will be conducted as follows : a screening performas will be distributed to those who are willing to participate those who fulfill the screening and inclusion exclusion criteria will be selected and then will be evaluated using ODI questionnaire, by checking SLR ,By measuring MMST and then pain on NPRS.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: age 18-45 years, Both Genders, Persons who sit for more than 3 hours, During SLR having pain at >70 degrees, Patients with Past three months of NSCLBP
Exclusion Criteria: Malignancy, Pregnancy, Disc Herniation, Fracture, Surgery in past 6 months
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Intervention groups
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After the evaluation and recruitment of participants , the participants will be equally distributed to two groups. Two Groups , Group 1 :PNF (Hold-Relax) stretching with Voodoo Floss band, Group 2:PNF (Hold-Relax) stretching. Both groups will have equal participants with base line treatment using TENS and Ultrasound on low back and the voodoo floss band will then be wrapped around thigh and the PNF technique will be performed in Three sessions per week for four weeks and the recordings will be taken at baseline week(2) and then at week(4) in clinic and hospital settings
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Main outcome variables
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SLR(Straight leg Raise test), NPRS(Numeric Pain Rating Scale), ODI(Oswestry Disability Index), MMST(Modified-Modified Schober's Test)
General information
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Reason for update
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There were some spelling mistakes, Postal code, Phone number mistakes, and Gmail mistakes due to typing errors. The corrections are made in the general section, Person responsible for general inquiries section , Person responsible for updating data section
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220510054807N1
Registration date:
2022-05-17, 1401/02/27
Registration timing:
registered_while_recruiting
Last update:
2022-07-15, 1401/04/24
Update count:
1
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Registration date
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2022-05-17, 1401/02/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-05-15, 1401/02/25
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Expected recruitment end date
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2022-08-31, 1401/06/09
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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EFFECTIVENESS OF PNF STRETCHING WITH OR WITHOUT VOODOO FLOSS BAND ON HAMSTRING FLEXIBILITY IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN
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Public title
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EFFECTIVENESS OF PNF STRETCHING WITH OR WITHOUT VOODOO FLOSS BAND ON HAMSTRING FLEXIBILITY IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18-45 Years
Both Genders
Persons who sit for more than 3 hours
patients with past three months of Non-specific Mechanical Chronic low back pain
Pain above 3 on NPRS
During SLR having pain at >70 degree
persons with minimum of 11 or more ODI score
less than 6cm difference on MMST
Exclusion criteria:
Persons with disc herniations
Patients with sciatic nerve pain are excluded
patients with fracture
Persons who had a surgery in past six months
Major surgeries like total Hip arthroplasty are also excluded
spinal trauma caused by accidents are excluded
pregnancy
Psychologically un-cooperative
Malignancy
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Age
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From 18 years old to 45 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
36
More than 1 sample in each individual
Number of samples in each individual:
18
Patients will be assigned into two groups. Each group will comprise of 18 patients.
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-03-20, 1400/12/29
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Ethics committee reference number
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09/05/2022
Health conditions studied
1
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Description of health condition studied
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Non-Specific chronic low back pain can be defined as pain in the lower lumbar region caused by strain or poor posture in the lumbar area associated with or caused by Hamstring tightness.
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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Straight leg raise test was used to measure the hamstring flexibilty in patients with Non-Specific Mechanical Chronic Low Back Pain
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Timepoint
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3time points including Baseline, 2nd Week Post Treatment, 4th Week Post Treatment
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Method of measurement
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SLR will be measured by Universal Goniometer
2
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Description
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NPRS(Numeric Pain Rating Scale was be utilized to measure the intensity of pain. Pain intensity was rated 0-10 at a horizontal bar. NPRS consists of 11 points, which range from 0=no pain, 1-4=mild pain, 4-7=moderate pain, 7-10=severe pain
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Timepoint
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3 time points including Baseline, 2nd Week Post Treatment, 4th Week Post Treatment
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Method of measurement
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NPRS will be utilized to assess pain
Secondary outcomes
1
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Description
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Lumbar Flexion Range of motion is assessed by the use of Modified-Modified Schober's Test. This test uses Tape measure to measure the lumbar flexion range. To measure the range of motion, the therapist puts his thumbs on the inferior margin of the subject’s PSIS. An ink mark is drawn along the midline of the lumbar spine horizontal to the PSIS (lower landmark). While the therapist holds the tape firmly against the subject’s skin, he marks a second line 15 cm above the original one (higher landmark). Then the subject is asked to do an active anterior flexion of the trunk without increasing the pain. The new distance between the lower and higher landmarks is then measured. The subject returns to the neutral position. The difference in the initial distance between the skin markings in the neutral position and the new measurements made in the flexion position is used to indicate the amount of lumbar flexion
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Timepoint
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3 time points, Baseline, 2nd Week post treatment,4th week post treatment
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Method of measurement
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MMST(Modified-Modified Schober's Test) will be utilized to measure Lumbar Flexion range
2
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Description
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ODI (Oswestry Disability Index) is a questionnair which measure low back pain function disability. It is a gold standard of low back functional outcome. There are 10 sections in this questionnair.Each section has six questions that score 0 to 5. Total score of all the sections is 50.Patients will fill the Questionnair and the scored will be (total possible score ) will be divided by 50 and then will be multiplied to 100 to get the percentage.0-20%=indicates minimal disability, 21-40%=Moderate Disability, 41-60%=Severe Disability, 61-80%=Crippled, 81-100%=These patients are either bed bound or exaggerating there symptoms.
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Timepoint
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3 Time Points Baseline, 2nd Week post treatment, 4th week post treatment
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Method of measurement
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ODI (Oswestry Disability Index) questionnaire will be utilized to measure Low back function
Intervention groups
1
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Description
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Intervention group 1:",Base line Treatment includes TENS (Transcutaneous Electrical Nerve Stimulation) will be used on lower back before actual treatment protocol,10 minutes in continuous mode (100 Hz with pulse duration of 50-100 micro second) and Therapeutic Ultrasound with 3 MHz for 10 minutes at 50% intensity (1.0 w/cm square, pulsed 50%). PNF(Hold-Relax) Stretching with Voodoo floss band, Voodoo floss band is a latex band black color has 2 inch width and 7 feet length is used to wrap around thighs with 50% stretch to compress blood flow around hamstring muscles and then PNF hold relax stretching technique is performed. Voodoo floss band will be wrapped around hamstrings , PNF includes Passive hamstring stretch by therapist held for 7 seconds, then 3 seconds isometric contract, 5 second relaxation, The physiotherapist then passively stretch the muscle until a mild stretch sensation is reported , 5 repetitions, , Each repetition is separated by 20 seconds , 3 sessions per week on alternative days for 4 weeks
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Category
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Rehabilitation
2
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Description
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Intervention group 2:",Base line Treatment includes TENS (Transcutaneous Electrical Nerve Stimulation) will be used on lower back before actual treatment protocol,10 minutes in continuous mode (100 Hz with pulse duration of 50-100 micro second) and Therapeutic Ultrasound with 3 MHz for 10 minutes at 50% intensity (1.0 w/cm square, pulsed 50%).PNF( Hold-Relax) Stretching includes Passive hamstring stretch by therapist held for 7 seconds, then 3 seconds isometric contract, 5 second relaxation, The physiotherapist then passively stretch the muscle until a mild stretch sensation is reported , 5 repetitions, , Each repetition is separated by 20 seconds , 3 sessions per week on alternative days for 4 weeks
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Self Financed
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable