Comparison of the effectiveness of Transcutaneous Electrical Nerve Stimulation along with Home Based Care Program in Postpartum Patients with Low Back Pain for Improving Pain, Disability and Quality of Life
The aim of the study is to compare the effects of Conventional Physical Therapy with and without Transcutaneous Electrical Nerve Stimulation in postpartum low back patients for improving pain, disability, and quality of life.
Design
A concealed, single-blinded, randomized controlled clinical trial with a parallel-group design of 70 patients,
Settings and conduct
70 subjects will be studied in Mansoora Hospital Department of Physical Therapy. Participants and assessors will be blinded. During the first visit, the researcher will complete thorough case history and regional assessment. Patients will be assessed using the SF36 for physical activity, general health, emotional activity, general health activity, and physical functions, Modified Oswestry Disability Index score for the functional outcome, and Numeric Pain Rating Scale for pain. In group A the patient will receive TENS and conventional Physical Therapy along with home-based exercises for back flexibility and strengthening and Group B will receive Conventional physical therapy along with home-based exercises. Participants were reassessed on the outcome scales at end of treatment.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Age range between 18 to 40 years
• Female having a normal delivery
• Female with six Week post-partum
• Female having low back pain of delivery
Exclusion Criteria
• Female with an anatomical anomaly
• Female with the structural disorder of spinal alignment (Scoliosis, kyphosis, lordosis)
• Female with Traumatic / Inflammatory / Infectious Conditions
• Female having diagnosed stress / depression / Anxiety
Intervention groups
Group A: TENS plus Conventional Physical Therapy (Supervised) with Home based exercises.
Group B: Conventional Physical Therapy (Supervised) with Home-based exercises
Main outcome variables
Pain, Disability, Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210205050256N2
Registration date:2021-09-03, 1400/06/12
Registration timing:registered_while_recruiting
Last update:2021-09-03, 1400/06/12
Update count:0
Registration date
2021-09-03, 1400/06/12
Registrant information
Name
Tooba Asif
Name of organization / entity
TIMES Institute
Country
Pakistan
Phone
+92 21 36410331
Email address
tooba573@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2022-01-01, 1400/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Transcutaneous Electrical Nerve Stimulation along with Home Based Care Program in Postpartum Patients with Low Back Pain for Improving Pain, Disability and Quality of Life
Public title
Effects of Transcutaneous Electrical Nerve Stimulation with Home-Based Program in Postpartum Patients with Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 18 to 40 years
Female who have normal delivery
Female with six week post-partum
Female having low back pain
In each group, 70 patients will be randomly distributed to two groups with the use of the lottery method of randomization. Slips will be prepared from 1 to 70. They will be homogeneous in shape, color, and size etc. Furthermore, they will be shuffled and will be placed in a box. The selected 35 slips will be allocated to Group 1, who will receive TENS plus supervised conventional home physical therapy program and the other 35 will be allocated to Group 2, who will receive conventional home physical therapy program.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor blinding: Every patient will be assessed by an independent assessor at the start and end of total treatment sessions to keep the assessment unbiased.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board
Street address
1 km Defence Road, Bhobatian Chowk. Lahore
City
Lahore
Postal code
54000
Approval date
2020-03-04, 1398/12/14
Ethics committee reference number
IRB/UOL/FAHS/719-II/2020
Health conditions studied
1
Description of health condition studied
Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low Back Pain
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Numeric Pain Rating Scale (NPRS)
2
Description
Disability
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Modified Oswestry Disability Index (MODI)
3
Description
Quality of Life
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Short-Form 36
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The patients in this group will receive TENS and conventional physical therapy along with home-based exercises. The electrodes of the TENS will be placed below shoulder blade level (T8), T10, L1, and sacral dimple level (S3). In conventional treatment, it will be hot pack and lumbar isometrics. Home-based exercises will include bridging, ankle pumps and straight leg raises with 1 set and 10 repetitions.
Category
Treatment - Devices
2
Description
Intervention group 2: The patients in this group will receive only conventional physical therapy along with home-based exercises. In conventional treatment, it will be a hot pack and lumbar isometrics. Home-based exercises will include bridging, ankle pumps and straight leg raises with 1 set and 10 repetitions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mansoora Hospital
Full name of responsible person
Dr. Farzana Shaukat
Street address
Multan Chungi, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35419510
Email
hirashafiq555@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Dr. Bilal Umar
Street address
1 km Defence Road, Bhobatian Chowk. Lahore
City
Lahore
Postal code
54000
Phone
+92 42 32300865
Email
info@uol.edu.pk
Grant name
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
20
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
Sponsor: country of origin
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
Dr. Bilal Umar
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 km Defence Road, Bhobatian Chowk. Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32300865
Email
info@uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Dr. Bilal Umar
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 km Defence Road, Bhobatian Chowk. Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32300865
Email
info@uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Hira Shafiq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1 km Defence Road, Bhobatian Chowk. Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32300865
Email
info@uol.edu.pk
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