Effects of Post-Isometric Relaxation Technique and Static Stretching of Quadratus Lumborum on Pain and Functional Disability in Patients with Mechanical Low Back Pain
To compare the effects of post-isometric relaxation technique and static stretching of quadratus lumborum with routine physical therapy on pain and functional disability in patients with mechanical low back pain.
Design
A concealed, randomized, single blinding, randomized clinical trail with a parallel group design of 78 patients.
Settings and conduct
Study was conducted in district head quarter hospital Narowal. Single blinding is done with blinding of assessor by labeling the experimental and control groups with unidentifying terms such as symbols or digits.
Participants/Inclusion and exclusion criteria
Participants of both gender with the age of 18 to 50 years having low back pain less than 12 weeks and visual analogue scale not less than point 3 are included in this study. Participants having specific low back pain such as lumber spondylosis, lumber canal stenosis, spondylolisthesis, sensory deficits, malignancies, tuberculosis, prolapsed intervertebral discs with instability or any radicular symptoms.
Intervention groups
Participants in control group received routine physical therapy and Participants in experimental group received Post-isometric relaxation technique and static stretching along routine physical therapy
Main outcome variables
Pain and Functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220922056020N1
Registration date:2023-06-24, 1402/04/03
Registration timing:retrospective
Last update:2023-06-24, 1402/04/03
Update count:0
Registration date
2023-06-24, 1402/04/03
Registrant information
Name
Rukhsar Amanat
Name of organization / entity
University Of Lahore
Country
Pakistan
Phone
+92 542 412110
Email address
ansarirukhsar822@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-01, 1401/03/11
Expected recruitment end date
2022-07-05, 1401/04/14
Actual recruitment start date
2022-07-18, 1401/04/27
Actual recruitment end date
2022-11-05, 1401/08/14
Trial completion date
empty
Scientific title
Effects of Post-Isometric Relaxation Technique and Static Stretching of Quadratus Lumborum on Pain and Functional Disability in Patients with Mechanical Low Back Pain
Public title
Post-isometric relaxation technique in Mechanical low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
low back pain less than 12 weeks.
Both gender.
Age 18 to 50 years.
VAS not less than point 3.
Exclusion criteria:
participants having specific low back pain
lumber spondylosis
lumber canal stenosis
sensory deficient
Malignancies
prolapse intervertebral discs with instability or any radicular symptoms
Tuberculosis
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
78
Actual sample size reached:
78
Randomization (investigator's opinion)
Randomized
Randomization description
non-probability sampling technique will be used to enroll the patients in intervention and control group and concealed envelop will be used for the random allocation.
we prepare opaque envelops which contain slip of paper that indicate the treatment allocation in control and interventional group. Then randomly assign the slip of paper to envelops, ensure concealment of treatment assignment. When participant enroll, they select the envelop randomly and assign the participant to the corresponding treatment without the knowledge of allocation. Then we open the envelop in the presence of participant and reveal the treatment assignment to maintain the transparency. Then repeat the process for subsequent participants and make ensure that the randomization is concealed and unbiased throughout the research.
Blinding (investigator's opinion)
Single blinded
Blinding description
single blinding study with blinding of assessor by labeling the experimental and control groups with unidentifying terms such as symbols or digits
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of university of Lahore
Street address
University of lahore new campus Defence road allied bank, lahore
City
Lahore \ narowal
Postal code
12345
Approval date
2022-07-18, 1401/04/27
Ethics committee reference number
173
Health conditions studied
1
Description of health condition studied
Mechanical low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
outcome measured first at baseline then at the follow up of 3rd week then at 6th week
Method of measurement
pain measured by visual analogue scale
2
Description
Functional disability
Timepoint
outcome measured first at baseline then at the follow up of 3rd week then at 6th week.
Method of measurement
Functional disability measured by modified oswestry disability index.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Participants received routine physical therapy which include TENS with Hot pack and exercises for the strengthening of muscles. Hot Moist pack: 10 mins for relaxing soft tissue structures and increase extensibility. Transcutaneous Electrical stimulator:10 mins for pain relief. Exercises: 10 repetitions- 5 sec hold for strengthening the muscles •Side bending •Side bridging• Pelvic bridging •Cat camel
Category
Treatment - Other
2
Description
Intervention group: Participants received Post-isometric relaxation technique and static stretching with routine physical therapy. Post-isometric relaxation technique: Thirty-nine participants received post-isometric relaxation technique for Quadratus lumborum. Position of the patient is side lying with uppermost arm fully extended. Position of the therapist; behind the patient at waist level. Inhale and abduct the uppermost leg and hold the leg and breathe for 7-10 seconds allowing the gravity to provide resistance. Patient then hang the leg behind him over the back of the table. Release the breath on slowly ceasing contraction. Therapist cradles the pelvis with both hands to take out all slack during exhalation. Hold stretch for 10 seconds. Patient relaxed for 20 seconds and same procedure was repeated for 5 times. Hot moist pack:10 mins for relaxing soft tissue structure, increases extensibility and pain relief. Transcutaneous Electrical stimulator:10 mins for pain relief. Exercises: 10 repetitions- 5 sec hold for strengthening the muscles• Side bending• Static abdominal• Static back extensor• Side bridging• Pelvic bridging• Cat camel
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
District head Quater Hospital Narowal
Full name of responsible person
Essa Shoukat Ali
Street address
Circular Road, Near Jassar By-pass, District Narowal, (Punjab) - Pakistan
City
Narowal
Postal code
51600
Phone
+92 333 5395197
Email
afifaamanat6@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Awais Rauf
Street address
University of lahore new campus Defence road allied bank, lahore
City
Lahore
Postal code
54000
Phone
+92 42 111 865 865
Email
info@uol.edu.pk
Web page address
http://www.UOLl.edu.pk
Grant name
Awais Rauf
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Awais Rauf
Street address
University of lahore new campus Defence road allied bank, lahore
City
Lahore
Postal code
54000
Phone
+92 42 111 865 865
Email
info@uol.edu.pk
Web page address
http://www.UOLl.edu.pk
Grant name
Awais Rauf
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Rukhsar Amanat
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ansari Mobile Phone Center Mohallah abbas nagar narowal
City
Narowal
Province
Punjab
Postal code
540000
Phone
+92 336 8784250
Email
afifaamanat6@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Rukhsar Amanat
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ansari Mobile Phone Center Mohallah abbas nagar narow
City
Narowal
Province
Punjab
Postal code
540000
Phone
+92 336 8784250
Email
afifaamanat6@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Al-shifa institute of health sciences
Full name of responsible person
Rukhsar Amanat
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ansari Mobile Phone Center Mohallah abbas nagar narowal
City
Narowal
Province
Punjab
Postal code
540000
Phone
+92 336 8784250
Email
afifaamanat6@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available