Effects of Manual Lymphatic Drainage on Pregnancy Induced Lumbo-Pelvic Pain
1 other identifier
interventional
38
1 country
1
Brief Summary
This study will be a randomized controlled trial. This study will be conducted in Civil Hospital, Hassan Abdal. A sample size of 32 patients will be taken. Patients will be divided into two groups by lottery method. Group A will be treated with hot pack followed by Manual Lymphatic Drainage while Group B will be given home based plan of hot pack application only. Both groups will receive treatment for 4 weeks,2 sessions per week. The outcome measures Numeric pain rating scale(NPRS), QOL-GRAV and Oswestry Disability Index for back. Data will be analyzed by SPSS 21.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable low-back-pain
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2022
CompletedFirst Posted
Study publicly available on registry
January 25, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedApril 11, 2022
April 1, 2022
6 months
January 21, 2022
April 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Numeric Pain Rating Scale (NPRS)
NPRS is a segmented version of Visual Analogue Scale (VAS). It consists of number from 0 to 10. Patient selects a number that best reflects his/her pain intensity where 0 is no pain and 10 is maximum pain. For construct validity, NPRS was highly correlated to Visual Analogue Scale (VAS) (0.86-0.95). The test-retest reliability of this scale is recorded to be 0.96. (Hawker et al. 2011)
4th week
Quality of Life Questionnaire for Physiological Pregnancy (QOL-GRAV)
The standardized QOL-GRAV questionnaire, focused on assessment of quality of life of pregnant women, was used to gather relevant data and to achieve the goals set. The results of the QOL-GRAV questionnaire are interpreted in such away that the lower the score, the higher the quality of life and the absence of problems associated with specific changes in pregnancy. The questionnaire assessed 4 domains: physical health, experience, social relationships and the environment .Based on the total score, the quality of life was assessed as excellent, very good, good, or not good.
4th week
Oswestry Disability Index for back
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.
4th week
Study Arms (2)
Manual Lymphatic Drainage and Hot pack
EXPERIMENTALHot Pack
ACTIVE COMPARATORInterventions
Application of hot pack for 20 minutes at low back in sitting, and then the participant will perform deep diaphragmatic breathing for 10 minutes, following these steps: 1. Sitting in comfortable position 2. One hand is placed over chest and other on abdomen. 3. Inhale deep through the nose. 4. Exhale through mouth, completely, counting back from 4 to 1. Application rotary or stationary circle over low back in side lying position, in pregnant females. A session of 20-30 minutes of Manual Lymphatic Drainage will be given biweekly. And at the end of Manual Lymphatic Drainage application, deep breathing for 10 minutes will be performed again.
Eligibility Criteria
You may qualify if:
- Expectant female with lumbopelvic pain
- Posterior pelvic pain
- Active Straight Leg Raise, Faber, Gaenslen and P4 test positive
- Pain \>3 on NPRS
- Females in 24- 36 weeks of pregnancy
You may not qualify if:
- Chronic back pain
- Cellulitis or erysipelas of the treated area
- Malignant disease of the treated area
- Disc herniation
- Lumbar/spinal surgical history
- Vertebral fracture
- Acute infection
- Uncontrolled hypertension
- High risk pregnancy
- History of fall or trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Civil Hospital
Hassan Abdal, Punjab Province, 44000, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hadia Nadeem, M.Phil PT
Riphah International University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2022
First Posted
January 25, 2022
Study Start
April 1, 2022
Primary Completion
October 1, 2022
Study Completion
November 1, 2022
Last Updated
April 11, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share