| CTRI Number |
CTRI/2023/10/058830 [Registered on: 18/10/2023] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of fascia activation technique in women having back pain after delivery |
|
Scientific Title of Study
|
Effect of Kinetic Chain Activation Technique on Lumbopelvic Rhythm, Spinal Curvature and Pelvic Alignment in Postpartum Pelvic Girdle Pain- A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima Sisodia |
| Designation |
MPT Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy,J.N. Medical College Campus, Nehru Nagar, Belagavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
07300003067 |
| Fax |
|
| Email |
mahima99.jdr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Huddar |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy, J.N. Medical College Campus, Nehru Nagar, Belagavi- 590010
KLE Institute of Physiotherapy, J.N. Medical College Campus, Nehru Nagar, Belagavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
7892677707 |
| Fax |
|
| Email |
drvarshabadli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Huddar |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy, J.N. Medical College Campus, Nehru Nagar, Belagavi- 590010
KLE Institute of Physiotherapy, J.N. Medical College Campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7892677707 |
| Fax |
|
| Email |
drvarshabadli@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
KLE Institute of Physiotherapy, J.N. Medical College Campus, Nehru Nagar, Belagavi-590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varsha Huddar |
Tertiary Care Hospital (Dr. Prabhakar Kore Hospital) |
Physiotherapy department, OPD no. 39.
Belgaum
KARNATAKA |
07892677707
mahima99.jdr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional exercises |
Isolated transverse abdominus contraction abdominal hallowing (AH) in supine position- 10 repetitions of each exercise.
Rhythmic contraction (contract and relax over one second)- 10–20 repetitions per set for 2 to 3 sets with an interval rest of 2 to 3 minutes.
Sustained contractions (contract and hold for up to 5-10 seconds and relax)
AH during bridging exercise- 10 repetitions of each exercise.
AH in alternating SLR (supported by therapist)- 10 repetitions of each exercise.
AH in alternating flexion and extension of knees as the feet slightly lift from the ground (supported by therapist)- 10 repetitions of each exercise.
Exercises involving hip extension, hip abduction, and abdominal crunches 10-20 repetitions. |
| Intervention |
KINETIC CHAIN ACTIVATION TECHNIQUE |
With patient in side lying/prone, posterior thigh tapping for 3-4 times from distal to proximal by physiotherapist followed by active knee flexion. This will be done for repetition of 3 times.
Tapping at lower lumbar region for 30-60 seconds to release thoracolumbar fascia, with patient either in standing or side lying/prone. This will be done for 3 times
Patient in side lying, therapist will give a release from distal to proximal thigh
with his/her medio-dorsal surface of proximal forearm for 2 repetitions.
Vaseline may be used for this |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Vaginal delivery childbirth
Both primiparous and multiparous
The onset of pain during pregnancy or within 3 weeks after delivery
PGP will be diagnosed on the basis of the following criteria:
Pain experienced distal to L5 and pain in the pelvic girdle region between the posterior iliac crest and the gluteal fold, with or without radiation in the posterior thigh, and with and without pain in the symphysis
Pain that is reproducible by at least two or more positive pelvic pain provocation tests (two tests bilaterally).
Pain when turning in bed. |
|
| ExclusionCriteria |
| Details |
Not willing to participate.
Complain of back pain before pregnancy.
Back pain indicating radiculopathy below knee
A history of neoplasm or spinal surgery, spinal or pelvic fracture, spinal deformity, severe trauma. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
LUMBOPELVIC RHYTHM
FLEXICURVE FOR SPINAL CURVATURE ASSESSMENT
PELVIC INCLINOMETER
PRESSURE BIOFEEDBACK
|
BEFORE AND AFTER TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VERBAL ANALOGUE SCALE
PELVIC GIRDLE QUESTIONNAIRE |
BEFORE AND AFTER INTERVENTION |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "13"
Final Enrollment numbers achieved (India)="13" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
24/10/2023 |
| Date of Study Completion (India) |
30/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postpartum pelvic girdle pain (PGP) is a prevalent condition stemming from pregnancy-related factors, with a substantial occurrence rate of 29.9%. Particularly, Indian women experience a notable prevalence of PGP, with 14.7% reporting pain within four weeks postpartum. Literatures suggest post-partum individuals seeking physical therapy (PT) beyond three months after delivery may experience minimal gains. Stabilizing exercises focused on transverse abdominis (TrA) and pelvic floor muscle (PFM) activity play a pivotal role in improving lumbo-pelvic stability. Co-contracting TrA and PFM effectively reduces vertical sacroiliac joint (SIJ) sheer forces, thereby enhancing SIJ stability. Empirical evidence underscores that stabilization exercises significantly alleviate pain and enhance TrA and PFM activity in postpartum lumbo-pelvic pain cases. Muscles and fascia are integral components of support and equilibrium. These changes during pregnancy cause asymmetrical tension lines which disrupt length-tension relationships, potentially affecting pelvic floor muscle action angles and contributing to an unstable sacroiliac joint. Furthermore, interventions targeting myofascial chains and interconnected connective tissues exhibit altered effects on strength and range of motion. For instance, the biceps femoris and erector spinae muscles, connected by the Sacro-tuberous ligament and lumbar fascia, form part of the superficial back line. Nevertheless, there is a scarcity of literature on myofascial meridian-based kinetic chain interventions for postpartum PGP. This study aims to explore the impact of kinetic chain activation techniques on musculoskeletal stability, with a focus on the anterior and posterior structures maintaining equilibrium between the two, supporting pelvic stability. By delving into the effectiveness of myofascial meridian-based interventions, this research seeks to shed light on their potential in alleviating postpartum pelvic girdle pain and enhancing overall functional well-being. |