Thermobalancing therapy and Dr Allen’s Device for the treatment of patients with chronic low back pain due to lumbar disc herniation or non-specific low back pain
To determine the effectiveness of thermobalancing therapy and Dr Allen’s Device for the treatment of patients with chronic low back pain (CLBP) due to lumbar disc herniation or non-specific low back pain
Design
Two arm parallel design randomized controlled trial.
Settings and conduct
The study will be conducted at Physical Therapy clinic of Government College University Faisalabad. Potential participants visiting clinic who fulfil edibility criteria will be provided with participant information sheet and if agree to participate, informed consent will be obtained. After baseline assessment participants will be randomized.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Subjects with chronic low back pain, age ≥18 years ≤ 70 years. Subjects should be diagnosed with lumbar disc herniation or nonspecific low back pain.
Exclusion criteria: patients with lumbar spinal stenosis, lumbar spondylolisthesis, lumbar scoliosis, or a history of lumbar spine surgery. Also, should be excluded people with severe comorbidities including cancer, heart failure and chronic infectious diseases.
Intervention groups
Participants in the treatment group will receive thermobalancing with Dr Allen’s Device for 3 months. Dr Allen’s Device consist of a soft belt, which contains thermoelement(s) from the special mixture of natural waxes, is used. Participants will be guided to wear the belt for maximum time throughout the daytime.
Patients in the control group will be placed in watchful waiting list and will not receive any active treatment.
Main outcome variables
Pain (Numerical Pain Rating Scale), functional disability (Roland Morris Disability Questionnaire) and low back pain symptoms (The Japanese Orthopedic Association Back Pain Evaluation Questionnaire) will be assessed at baseline, after 1 and 3 months after the treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211022052833N2
Registration date:2023-04-09, 1402/01/20
Registration timing:prospective
Last update:2023-04-09, 1402/01/20
Update count:1
Registration date
2023-04-09, 1402/01/20
Registrant information
Name
Aatik Arsh
Name of organization / entity
Khyber Medical University
Country
Pakistan
Phone
+92 937 576111
Email address
aatikarsh@kmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-10, 1402/01/21
Expected recruitment end date
2023-06-25, 1402/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Thermobalancing therapy and Dr Allen’s Device for the treatment of patients with chronic low back pain due to lumbar disc herniation or non-specific low back pain
Public title
Thermobalancing therapy for low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects, age greater than 18 years and less than 70 years with chronic low back pain
Subjects with diagnosis of lumbar disc herniation or nonspecific low back pain
Exclusion criteria:
Subjects with lumbar spinal stenosis, lumbar spondylolisthesis, lumbar scoliosis, or a history of lumbar spine surgery
Subjects with severe comorbidities including cancer, heart failure and chronic infectious diseases
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
After completion of baseline Case report form, the participants (individuals) will be randomized to either the treatment or control group. Through simple randomization methods, participants will be randomized based on 1:1 allocation ratio. The randomization will be performed online based on a computer-generated randomization sequence using Openepi (www.openepi.com). The random sequence obtained from Openepi software will be stored with the trial data manager. After recruitment of the participant, research assistant will inform trial data manager to generate a randomization link from the software for the participant. After generating randomization link by the trial data manager, a research assistant will open the randomization link which will show the assigned group for the participants. The participant will be allocated to either treatment group or control group accordingly. The allocation will not be concealed as trail data manager, research assistant and participant will be aware of the allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Review Committee of the Government College University Faisalabad
chronic low back pain due to lumbar disc herniation or nonspecific low back pain
ICD-10 code
M54.56
ICD-10 code description
Low back pain, lumbar region
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and 1, 3 months after intervention
Method of measurement
Numerical Pain Rating Scale
2
Description
Disability
Timepoint
Before intervention and 1, 3 months after intervention
Method of measurement
Roland Morris Disability Questionnaire
3
Description
Low back pain symptoms
Timepoint
Before intervention and 1, 3 months after intervention
Method of measurement
The Japanese Orthopedic Association Back Pain Evaluation Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in the treatment group will receive thermobalancing with Dr Allen’s Device for 3 months. Dr Allen’s Device consist of a soft belt, which contains thermoelement(s) from the special mixture of natural waxes, is used. Participants will be guided to wear the belt for maximum time (for at least 8 hours a day) throughout the daytime. A physical therapist will guide the participants how to wear the belt and how to remove it. Participants will be guided to note the number of days, on which they are not wearing the belt due to any reason. Participants will use diary to report the use and non-use of the belt.
Category
Treatment - Devices
2
Description
Control group: Patients in the control group will be placed in watchful waiting list and will not receive any active treatment.