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Effects of Manual Lymphatic Drainage on Pregnancy Induced Lumbo-Pelvic Pain

Primary Purpose

Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Manual Lymphatic Drainage and Hot Pack
Hot Pack
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, manual lymphatic drainage, pregnancy

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • • 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

Sites / Locations

  • Civil Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual Lymphatic Drainage and Hot pack

Hot Pack

Arm Description

Outcomes

Primary Outcome Measures

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)
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2022
Last Updated
April 2, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05206851
Brief Title
Effects of Manual Lymphatic Drainage on Pregnancy Induced Lumbo-Pelvic Pain
Official Title
Effects of Manual Lymphatic Drainage on Pregnancy Induced Lumbo-Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Low back pain is a common complaint among pregnant females. This pain is felt between area of 12th rib and gluteal fold. Pelvic girdle pain(PGP) is proficient among the posterior iliac crest and the gluteal fold, chiefly in the area of the sacroiliac joints and/or in the symphysis pubis. Low back pain is frequent cause for visiting doctor in pregnancy and is related with changed quality of life amongst pregnant females. Health and quality of life of expectant females should be incorporated in the scope of pregnancy routine follow up and precautionary health programs. Several researchers studied the effect of passive therapeutic techniques to reduce pregnancy induced low back pain. These treatment approaches were compared with active therapeutic techniques (exercise based interventions) or used in combination with active treatment mode to enhance the pain alleviation. Pregnancy is also associated with lower limb edema due to increase progesterone level that causes blood vessels to relax, making it difficult for blood to return toward heart from lower limb. Most common treatment to reduce edema is Manual Lymphatic Drainage. Manual lymph drainage or Keser I, Esmer M.2019 Manual Lymphatic Drainage is done by a gentle massage on the skin that enhances smooth muscle contraction of the superficial lymphatic vessels and increases the lymphatic flow. Manual Lymphatic Drainage not only reduces edema but also reduce pain along with it. Manual Lymphatic Drainage application is detected by receptors in the skin. It provides the basis of analgesic effect of Manual Lymphatic Drainage. During application of Manual Lymphatic Drainage, numerous adjoining touch receptors are fondled in sequence. Consequently, every receptor directs action potentials at the commencement and termination of the contact, these action potentials prevent the pain. Drouin JS, Pfalzer L, Shim JM, Kim SJ. 2020 Manual lymph drainage is indicated for reduction of edema of limbs, to reduce pain and fatigue in gravid females. Manual Lymphatic Drainage is also indicated to manage lymphedema succeeding cancer managements and to lessen pain and improve edema instigated by venous ailments, any surgery, and trauma or due to primary lymphedema. Schingale F-J, Esmer M, Küpeli B, Ünal D. 2021 Manual lymph drainage increase parasympathetic activity and reduce sympathetic activity, increase pain threshold and pain tolerance, improve regeneration and repair of skeletal muscles, increases venous blood recycling, also pain regulation pathway inhibition is Manual Lymphatic Drainage's neural effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, manual lymphatic drainage, pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual Lymphatic Drainage and Hot pack
Arm Type
Experimental
Arm Title
Hot Pack
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Manual Lymphatic Drainage and Hot Pack
Intervention Description
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: Sitting in comfortable position One hand is placed over chest and other on abdomen. Inhale deep through the nose. 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.
Intervention Type
Other
Intervention Name(s)
Hot Pack
Intervention Description
Hot pack will be applied at low back, for 20 minutes as home based protocol.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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)
Time Frame
4th week
Title
Quality of Life Questionnaire for Physiological Pregnancy (QOL-GRAV)
Description
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.
Time Frame
4th week
Title
Oswestry Disability Index for back
Description
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.
Time Frame
4th week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 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 Exclusion Criteria: • 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadia Nadeem, M.Phil PT
Phone
+923351852442
Email
hadia.nadeem@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
+923324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadia Nadeem, M.Phil PT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Civil Hospital
City
Hassan Abdal
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadia Nadeem, M. Phil
Phone
+923351852442
Email
hadia.nadeem@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Rida Zafar, MSPT*
Phone
+923368753273
Email
zafarrida79@gmail.com
First Name & Middle Initial & Last Name & Degree
Rida Zafar, MSPT*

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Manual Lymphatic Drainage on Pregnancy Induced Lumbo-Pelvic Pain

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