Clinical trial NCT05206851: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
manual lymphatic drainage
pregnancy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 4th week
measure: Quality of Life Questionnaire for Physiological Pregnancy (QOL-GRAV)
timeFrame: 4th week
measure: Oswestry Disability Index for back
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Hassan Abdal
country: Pakistan
facility: Civil Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hadia Nadeem, M.Phil PT
role: PRINCIPAL_INVESTIGATOR
References: