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Pelvic Girdle PainNCT05787158

Effects of Muscle Energy Techniques Versus Core Stability Exercises in Pelvic Girdle Pain

A study testing Muscle energy techniques in people with Pelvic Girdle Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

PGP is referred to as a specific form of LBP which occurs isolatedly as well as in combination with lumbar back pain. PGP localized to the anterior or posterior pelvis, most commonly located between the posterior iliac crest and gluteal folds especially around the SI joint. Read more about this study

Who is it for?
Ages 25 to 35 years
Conditions the study is for
Pelvic Girdle Pain
What is being tested?
Muscle energy techniques
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 sitePakistan
Study dates
2 Feb 2022to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females of 25 to 40 years were included in this study.(20)
  • Female patients who gave birth at least 6 months before.(20)
  • Females who gave birth through vaginal delivery.(20)
  • Females with at least three positive pain provocative tests such as posterior pelvic pain provocation test (P4), active straight leg raise test (ASLR), thigh thrust, Patrick's Faber test, Gaenslen's test and distraction test.(20)
  • History of pain around the pelvic girdle, lower back or between the posterior iliac crest and the gluteal fold, difficulty in walking and/or pain when putting weight on one leg

Who cannot join

  • Females who suffered from grade 3 or 4 vaginal tears during their pregnancy (20)
  • Females who underwent episiotomy during delivery (20)
  • Females who delivered through caesarean section (20)
  • Postpartum females with a history of trauma to the pelvic region (20)
  • Postpartum females with a history of pelvic surgery
  • Postpartum females with a history of other orthopedic disorders

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Ghurki Trust Teaching Hospital.

    Lahore, Punjab Province, 05499

Other trials in Pakistan

About this study

PGP is referred to as a specific form of LBP which occurs isolatedly as well as in combination with lumbar back pain. PGP localized to the anterior or posterior pelvis, most commonly located between the posterior iliac crest and gluteal folds especially around the SI joint. Pelvic girdle pain radiated to the posterior thigh

Read the detailed description

Pelvic girdle pain (PGP) is known to be a musculoskeletal disorders which affects the pelvic bone. PGP is referred to as a specific form of LBP which occurs isolatedly as well as in combination with lumbar back pain. PGP localized to the anterior or posterior pelvis, most commonly located between the posterior iliac crest and gluteal folds especially around the SI joint. Pelvic girdle pain radiated to the posterior thigh. Moreover, it can also cause pain in the symphysis (1). Compared to lower back pain, PGP is substantially more painful and linked with functional limitations as standing, walking, sitting and changing positions are less tolerable in such patients (2). PGP is musculoskeletal in nature and is not caused by gynecological or urological conditions (3). Despite the fact that the cause of PGP is unknown, it is considered that it occurs due to many reasons such as trauma, arthritis, anatomical fault or it can be associated with pregnancy (4

Being tested
Muscle energy techniques
Medical subject headings
Pelvic Girdle Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Muscle energy techniquesOther

    Also called core stability exercises

    Group A: 20 patients were included in this group. This studygroup was assigned with basic treatment protocol with 15 minutes of TENS and thermal therapy for 10 minutes followed by muscle energy technique (Post facilitation stretching exercises). The intervention was given three days per weekfor six weeks. Each total session lasted for 45minutes. METs were applied for the weakened muscles. (21). Group B: 20 Patients of this group were given core stability exercises by the female physical therapist in three different levels. Each level continued for a duration of two weeks in which the patients were trained for the exercises. The patients were provided sessions thrice per week with 2 sets of 10 repetitions and a hold of 10 second after TENS for 15 minutes and thermal therapy for 10 minutes

Study groups in NCT05787158
Study groupRoleWhat they receive
Group AExperimentalGroup A: 20 patients were included in this group. This studygroup was assigned with basic treatment protocol with 15 minutes of TENS and thermal therapy for 10 minutes followed by muscle energy technique (Post facilitation stretching exercises). The intervention was given three days per weekfor six weeks. Each total session lasted for 45minutes. METs were applied for the weakened muscles.
Receives: Other: Muscle energy techniques
Group BActive comparatorGroup B: 20 Patients of this group were given core stability exercises by the female physical therapist in three different levels. Each level continued for a duration of two weeks in which the patients were trained for the exercises. The patients were provided sessions thrice per week with 2 sets of 10 repetitions and a hold of 10 second after TENS for 15 minutes and thermal therapy for 10 minutes.
Receives: Other: Muscle energy techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VISUAL ANALOGUE SCALE

    Visual Analogue scale is a numeric scale ranging from 1 to 10. These ranges show the intensity of pain where 1 shows no pain and 10 shows worst pain imaginations. It is a very reliable and valid tool with test-retest reliability of r = 0.96 and validity correlations of 0.86 to 0.95.

    Measured: 12 weeks

  2. OSWESTRY DISABILITY INDEX

    Oswestry Disability Index was calculated in order to find out the disability among patients. ODI evaluates disability related to Activities of Daily Living. This is considered to be the best tool for evaluating low back issues. It encompasses 10 questions with each question scoring five. Questions related to pain, personal care, walking, standing, lifting, sitting, sex life, sleeping, social life and travelling are included. The interpretation shows minimal disability if the patient score is 0-20%, moderate disability if the score is 20-40%, 40 - 60% severe disability, 60 - 80% crippled and 80 - 100 % depicting that the patient is either bed bound or overly expressing the symptoms

    Measured: 12 weeks

  3. SF - 36

    This questionnaire is used to assess the functional performance in different domains of life like physical, body pain, mental, social and psychological. The questionnaire encompasses questions based on 7 domains of life. The minimum score of SF-36 is 0 which means that the functional performance is worst whereas the highest score is 100 which means that functional performance is best

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2023
  2. Study start2 Feb 2022
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05787158
Sponsor's protocol ID
REC/RCR & AHS/22/0546
Status last verified
Mar 2023
First submitted
15 Mar 2023
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.

    PubMed 30839304

  • Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.

    PubMed 30282349

  • Teymuri Z, Hosseinifar M, Sirousi M. The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Dec;97(12):885-891. doi: 10.1097/PHM.0000000000000993.

    PubMed 29979205

  • Almousa S, Lamprianidou E, Kitsoulis G. The effectiveness of stabilising exercises in pelvic girdle pain during pregnancy and after delivery: A systematic review. Physiother Res Int. 2018 Jan;23(1). doi: 10.1002/pri.1699. Epub 2017 Nov 8.

    PubMed 29115735

Questions about this trial

What is this clinical trial studying?

A study testing Muscle energy techniques in people with Pelvic Girdle Pain, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VISUAL ANALOGUE SCALE (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05787158, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

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