COMPARISON OF DRY NEEDLING AND SPINAL MANIPULATIVE THERAPY VERSUS SPINAL MANIPULATIVE THERAPY ALONE ON PAIN AND DISABILITY IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN
To determine the effects of dry needling combined with spinal manipulative therapy versus spinal manipulative therapy alone on pain, disability, lumbar range of motion (ROM) and muscle endurance in patients with non-specific chronic low back pain.
Design
Two arm parallel group randomised trial with blinded outcome assessment
Settings and conduct
Setting is Sindh Institute of Physical Medicine and Rehabilitation. Outcome assesor will be blinded to the treatment intervention.
Participants/Inclusion and exclusion criteria
Patients diagnosed as having chronic nonspecific low back pain will be included in the study. Any serious spinal pathology will be excluded
Intervention groups
After random allocation of the participants into two groups, experimental group will receive spinal manipulative therapy and dry needling while the control group will receive spinal manipulative therapy alone.
Main outcome variables
Pain, lumbar range of motion, disability and lumbar muscle endurance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200826048530N1
Registration date:2023-10-01, 1402/07/09
Registration timing:retrospective
Last update:2023-10-01, 1402/07/09
Update count:0
Registration date
2023-10-01, 1402/07/09
Registrant information
Name
Kashmala Khan
Name of organization / entity
University of Lahore+Dow university of health science
Country
Pakistan
Phone
+92 21 99216213 ext. 6127
Email address
kashmalakhan.2516@duhs.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2022-12-29, 1401/10/08
Actual recruitment start date
2019-02-04, 1397/11/15
Actual recruitment end date
2022-12-29, 1401/10/08
Trial completion date
2022-12-29, 1401/10/08
Scientific title
COMPARISON OF DRY NEEDLING AND SPINAL MANIPULATIVE THERAPY VERSUS SPINAL MANIPULATIVE THERAPY ALONE ON PAIN AND DISABILITY IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN
Public title
DRY NEEDLING AND SPINAL MANIPULATIVE THERAPY VERSUS SPINAL MANIPULATIVE THERAPY ALONE IN NON-SPECIFIC CHRONIC LOW BACK PAIN
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients willing to be part of the study
Patients diagnosed as having chronic nonspecific low back pain
Age 18 –60 years
Both male and female
History of non-specific LBP without referral into the lower extremity
Score 4 points on the Roland Morris Disability Questionnaire
Have not received physical therapy within the last 3 months
Exhibit at least 1 active TrP reproducing their symptom in quadratus lumborum , gluteus medius and paraspinal muscle
Exclusion criteria:
Any serious spinal pathology (e.g. inflammatory or infectious condition of the spinemetastatic fracture, cauda-equina syndrome etc)
Compromised nerve root
Any history of spinal surgery
Any other conditions that would affect the active participation in the treatment.
Long term steroid use
Any neurological condition
Osteoporosis
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
128
Actual sample size reached:
128
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects are randomly assigned to one of two groups by using simple randomization method using computer-generated random numbers and the random sequence is built with the computer generated software. The unit of the randomization is individual patient. The allocation concealment is carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single blinded randomized controlled trial in which assessor (another PT) will not be aware of the treatment groups. The principal investigator has to perform all the treatment sessions so it would not be possible to be blinded. Also, the participant cannot be blinded because of the different nature of interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Instituitional Review Board of the University of Lahore
Street address
1-Km Defence Road،, near Bhuptian Chowk،
City
Lahore
Postal code
54000
Approval date
2019-01-07, 1397/10/17
Ethics committee reference number
IRB-UOL-FAHS/670-1/2019
Health conditions studied
1
Description of health condition studied
Non-specific chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pian intensity
Timepoint
before intervent and 4, 8 weeks, 6 months after intervention
Method of measurement
Visual Analogue Scale (VAS-0 to 10cm) for pain intensity. increase in scores suggests increase in pain intensity and decrease suggests decrease in pain intensity.
2
Description
Range of motion of lumbar spine
Timepoint
before intervent and 4, 8 weeks, 6 months after intervention
Method of measurement
Modified-modified Schöber Test to measure flexion of lumbar spine.
3
Description
Disability
Timepoint
before intervent and 4, 8 weeks, 6 months after intervention
Method of measurement
Ronald Morris Disability Questionnaire (RMDQ) for disability
Secondary outcomes
1
Description
Lumbar muscle endurance
Timepoint
before intervent and 4, 8 weeks, 6 months after intervention
Method of measurement
Sorensen test for lumbar muscle endurance
Intervention groups
1
Description
Intervention group: Spinal manipulative therapy and dry needling (DN). Participants allocated to this group will recieve both Spinal manipulative therapy and dry needling. For the spinal manipulative therapy, patient will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis. The particular dose and techniques will be at the discretion of the treating physical therapist, based on each participant’s physical examination findings. After this the Active TrPs located in the gluteus medius and quadratus lumborum muscles will be treated with DN. These muscles will be chosen because active TrPs are prevalent in patients with chronic mechanical LBP. The disposable stainless steel needles (0.25 × 32 mm and0.25 × 32 mm) that will be inserted through the skin over the active TrP. In this study, the fast-in and fast-out technique described by Hong will be applied. After locating an active TrP, the overlying skin will be cleaned with alcohol, and the needle will be subsequently inserted, penetrating the skin and muscle till 16 to 20 mm into the TrP. The position of the patient will be side lying. Once inserted into the TrP, the needle will be moved in multiple directions until the first local twitch response is obtained. Once the first local twitch response willl be obtained, the needling will be performed in an up and down fashion, at approximately 1 Hz for 25 to 30 seconds with the aim of eliciting different local twitch responses. The interventions will be provided by a clinician with 10 years of experience. Total number of intervention session is 12 with intervention duration is set is 8 weeks, comprising of an hourly session with a frequency of two session per week for manipulative therapy including one day treatment of DN till 4th week and after that one session of manipulative therapy plus DN per week.
Category
Rehabilitation
2
Description
This group will recieve spinal manipulative therapy only. The patient will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis . The particular dose and techniques will be at the discretion of the treating physical therapist, based on each participant’s physical examination findings.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sindh Institute of Physical Medicine and Rehabilitation
Full name of responsible person
Kashmal Khan
Street address
Chand Bibi Rd، near Mujahid Masjid, Deli Colony Ranchore Lane
City
Karachi
Postal code
74200
Phone
+92 21 99216212
Email
info@sipmr.edu.pk
Web page address
https://sipmr.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sindh Institute of Physical Medicine and Rehabilitation
Full name of responsible person
Prof. Dr. Nabila Najam Soomro
Street address
Chand Bibi Rd، near Mujahid Masjid, Deli Colony Ranchore Lane
City
Karachi
Postal code
74200
Phone
+92 21 99216213
Email
info@sipmr.edu.pk
Web page address
http://sipmr.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
context and facilities for the conduct of trial
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Sindh Institute of Physical Medicine and Rehabilitation
Full name of responsible person
Kashmala
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Chand Bibi Rd، near Mujahid Masjid, Deli Colony Ranchore Lane
City
Karachi
Province
Sindh
Postal code
74200
Phone
+92 21 99216213
Email
kashmala_khan84@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sindh Institute of Physical Medicine and Rehabilitation
Full name of responsible person
Kashmala
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Chand Bibi Rd، near Mujahid Masjid, Deli Colony Ranchore Lane
City
Karachi
Province
Sindh
Postal code
74200
Phone
+92 21 99216213
Email
kashmala_khan84@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sindh Institute of Physical Medicine and Rehabilitation
Full name of responsible person
Kashmala
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Chand Bibi Rd، near Mujahid Masjid, Deli Colony Ranchore Lane
City
Karachi
Province
Sindh
Postal code
74200
Phone
+92 21 99216213
Email
kashmala_khan84@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in physical medicine rehabilitation and low back pain.