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Status unknownNCT05206851Updated Apr 11, 2022

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

An interventional study of Manual Lymphatic Drainage and Hot Pack and Hot Pack in Low Back Pain, sponsored by Riphah International University. Status unknown at 1 site in Pakistan. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-04-11.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

  • Low Back Pain

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Keywords

  • low back pain
  • manual lymphatic drainage
  • pregnancy
03

In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's planned enrollment of 38 is below the median of 60 across 2,315 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,176 studies on the registry; 637 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Manual Lymphatic Drainage and Hot pack

    Other: Manual Lymphatic Drainage and Hot Pack

  • Active comparator
    Hot Pack

    Other: Hot Pack

Interventions

  • OtherManual Lymphatic Drainage and Hot Pack

    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.

  • OtherHot Pack

    Hot pack will be applied at low back, for 20 minutes as home based protocol.

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 4th week

  2. 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.

    Time frame: 4th week

  3. 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.

    Time frame: 4th week

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Study locations

1 site
  • Civil Hospital
    Hassan Abdal, Punjab Province 44000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05206851
Responsible party
Sponsor
First posted
Jan 25, 2022
Start date
Apr 2022 (estimated)
Primary completion
Oct 2022 (estimated)
Completion
Nov 2022 (estimated)
Last update
Apr 11, 2022

Study contacts

Hadia Nadeem, M.Phil PT
Contact
hadia.nadeem@riphah.edu.pk
+923351852442
Imran Amjad, PhD
Contact
imran.amjad@riphah.edu.pk
+923324390125
Hadia Nadeem, M.Phil PT
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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