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Chronic Pelvic PainNCT05851742

Effects of Myofascial Release and Electrical Stimulation in Chronic Pelvic Pain

A study testing TENS and Myofascial trigger point release in people with Chronic Pelvic Pain and Myofascial Trigger Point Pain, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor to chronic pelvic pain in women.In females,pelvic pain is the single most common indication for referral to women's health services.Pelvic floor physical therapy with myofascial release improve mobility and reduce pain by… Read more about this study

Who is it for?
Ages 25 to 45 years, women only
What is being tested?
TENS and Myofascial trigger point release
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 sitePakistan
Study dates
1 Jan 2023to 1 Aug 2023
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 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 25-40 years,
  • Presence of persistent chronic pelvic pain
  • >4 points on a 10 point numeric rating scale for atleast more than 3 months,
  • Atleast 1 active MTrp in one of the muscle groups including the obturator internus,
  • levator ani,piriformis and coccygeus on pelvic examination.

Who cannot join

  • Prolapse of the pelvic organ,
  • Pregnency,
  • Fibromyalgia

Trial locations and contacts

1 site in 1 country.

Imran Amjad, Phd contact

03324390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Jinnah Hospital Lahore

    Lahore, Punjab Province

    Hafiza Mehjabeen, MSWHPT, 03026577666, mehjabeen@riphah.edu.pk

    Sitara Farasat, DPT

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Myofascial Release With and Without Electrical Stimulation on Pain and Functionality in Women With Chronic Pelvic Pain

Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor to chronic pelvic pain in women.In females,pelvic pain is the single most common indication for referral to women's health services.Pelvic floor physical therapy with myofascial release improve mobility and reduce pain by releasing the painful trigger points.Tools that will be used,for pain numerical pain scale (NPS),functional pelvic pain scale(FPPS) and pelvic floor impact questionnaire-7 will be used to asses pain and functionality.

Read the detailed description

Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor to chronic pelvic pain in women. In females, pelvic pain ''is the single most common indication for referral to women's health services. Pelvic floor physical therapy with myofascial release improve mobility, and reduce pain by releasing the painful trigger points following restrictions in connective tissues that are related to pelvic floor.In this project we will observe effects of myofascial release with and without electrical stimulation on pain and functionality in women with chronic pelvic pain.It has been hypothesized that myofascial release along with electrical stimulation help in reducing pain and improve functionality in women.Patients will be having sessions for consecutive 4 weeks and will be exposed to both types of techniques to find out the effective results.

The study will be randomized control trial.For pain numerical pain scale (NPS),functional pelvic pain scale(FPPS) and pelvic floor impact questionnaire-7 will be used to asses pain and functionality respectively. A randomized control trial will be conducted on two groups. Group 1 will receive myofascial release with electrical stimulation in women with chronic pelvic pain for 4 weeks with 50-280 Hz frequency and a pulse duration of 50 µs for 10 minutes along with 10 minutes myofascial release..On the other hand Group 2 will receive myofascial release without electrical stimulation on pain and functionality in women with chronic pelvic pain. In previous studies there is ample amount of research conducted on chronic pelvic pain but there were very few recent studies available on myofascial release,so this relation of use of myofascial release with and without electrical stimulation on pain and functionality in chronic pelvic pain should also be carried out.

Being tested
TENS, Myofascial trigger point release
Keywords
chronic pelvic pain syndrome, pelvic floor physical therapy, myofascial release, myofascial trigger points
Medical subject headings
Myofascial Pain Syndromes

What participants receive

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

  • TENSDevice

    TENS 50-280 HZ frequency and a pulse duration of 50 us for 10 minutes along with 10 minutes myofascial release.

  • Myofascial trigger point releaseOther

    Release of trigger points

Study groups in NCT05851742
Study groupRoleWhat they receive
Mfofascial release with electrical stimulationActive comparatorTENS 50-280 HZ frequency and a pulse duration of 50 us for 10 minutes along with 10 minutes myofascial release.
Receives: Device: TENS
Myofascial release without electrical stimulationExperimentalRelease of trigger points
Receives: Other: Myofascial trigger point release

What is being measured

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

  1. NPRS (Numeric Pain Rating Scale)

    Higher the numeric value is 10 and lower is 0.The patient is asked to make three pain ratings corresponding to current,best and worst pain experienced over the past 24 hours on a scale of 0(no pain)to 10(worst pain imaginable).The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.

    Measured: 4 weeks

  2. FPPS (Functional Pelvic Pain Scale)

    Patients score pelvic function on the FPPS form for 8 categories:Bladder,Bowel,Intercourse,Walking,Running,Lifting,Working,Sleeping.The patients rated each category from 0 to 4,with 0 for normal function and 4 for cannot function because of pain.Thus each patient was given a total pelvic function score between 0 and 32.

    Measured: 4 weeks

  3. PFIQ-7 (Pelvic Floor Impact Questionaire)

    The PFIQ-7 consists of 7-questions that need to be answered 3 times each considering symptoms related to the Bladder or urine,Bowel or rectum,Vagina or pelvis and their effects on function,social health and mental health in the past 3 months.The responses for each question range from "Not at all-Somewhat-Moderately-Quit a bit". To get scale scores,the mean of each of the 3 scales is individually calculated,which ranges from 0 to 3,this number is then multiplied by 100 and then divided by 3.The scale scores are then added together to get the total PFIQ-7 score,which ranges from 0 to 300.A lower score means there is a lesser effect on quality of life.

    Measured: 4 weeks

Timeline

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

  1. First posted10 May 2023
  2. Study start1 Jan 2023
  3. Primary completion1 Jul 2023 (estimated)
  4. Study completion1 Aug 2023 (estimated)

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
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05851742
Sponsor's protocol ID
REC/RCR & AHS/23/0507
Status last verified
May 2023
First submitted
31 Mar 2023
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shrikhande A, Ullger C, Seko K, Patil S, Natarajan J, Tailor Y, Thompson-Chudy C. A physiatrist's understanding and application of the current literature on chronic pelvic pain: a narrative review. Pain Rep. 2021 Aug 30;6(3):e949. doi: 10.1097/PR9.0000000000000949. eCollection 2021 Sep-Oct.

    PubMed 34476302
  • Castro-Sanchez AM, Gil-Martinez E, Fernandez-Sanchez M, Lara-Palomo IC, Nastasia I, de Los Angeles Querol-Zaldivar M, Aguilar-Ferrandiz ME. Manipulative therapy of sacral torsion versus myofascial release in patients clinically diagnosed posterior pelvic pain: a consort compliant randomized controlled trial. Spine J. 2021 Nov;21(11):1890-1899. doi: 10.1016/j.spinee.2021.05.002. Epub 2021 May 13.

    PubMed 33991702
  • Halder GE, Scott L, Wyman A, Mora N, Miladinovic B, Bassaly R, Hoyte L. Botox combined with myofascial release physical therapy as a treatment for myofascial pelvic pain. Investig Clin Urol. 2017 Mar;58(2):134-139. doi: 10.4111/icu.2017.58.2.134. Epub 2017 Feb 1.

    PubMed 28261683
  • Aredo JV, Heyrana KJ, Karp BI, Shah JP, Stratton P. Relating Chronic Pelvic Pain and Endometriosis to Signs of Sensitization and Myofascial Pain and Dysfunction. Semin Reprod Med. 2017 Jan;35(1):88-97. doi: 10.1055/s-0036-1597123. Epub 2017 Jan 3.

    PubMed 28049214
  • Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019 Dec;35(12):1131-1138. doi: 10.1080/09593985.2018.1472687. Epub 2018 May 14.

    PubMed 29757068
  • Vural M. Pelvic pain rehabilitation. Turk J Phys Med Rehabil. 2018 Nov 4;64(4):291-299. doi: 10.5606/tftrd.2018.3616. eCollection 2018 Dec.

    PubMed 31453525
  • Sharma N, Rekha K, Srinivasan JK. Efficacy of transcutaneous electrical nerve stimulation in the treatment of chronic pelvic pain. J Midlife Health. 2017 Jan-Mar;8(1):36-39. doi: 10.4103/jmh.JMH_60_16.

    PubMed 28458478
  • Dal Farra F, Aquino A, Tarantino AG, Origo D. Effectiveness of Myofascial Manual Therapies in Chronic Pelvic Pain Syndrome: A Systematic Review and Meta-Analysis. Int Urogynecol J. 2022 Nov;33(11):2963-2976. doi: 10.1007/s00192-022-05173-x. Epub 2022 Apr 7.

    PubMed 35389057
  • Lewis GK, Chen AH, Craver EC, Crook JE, Carrubba AR. Trigger point injections followed by immediate myofascial release in the treatment of pelvic floor tension myalgia. Arch Gynecol Obstet. 2023 Apr;307(4):1027-1035. doi: 10.1007/s00404-022-06880-y. Epub 2022 Dec 14.

    PubMed 36513896
  • Natarajan J, Ahmed T, Patil S, Mamsaang M, Kapadia R, Tailor Y, Shrikhande A. Pain and functionality improved when underlying neuromuscular dysfunction addressed in chronic pelvic pain patients. Neurourol Urodyn. 2021 Aug;40(6):1609-1615. doi: 10.1002/nau.24726. Epub 2021 Jun 3.

    PubMed 34082473
  • Ajimsha MS, Ismail LA, Al-Mudahka N, Majzoub A. Effectiveness of external myofascial mobilisation in the management of male chronic pelvic pain of muscle spastic type: A retrospective study. Arab J Urol. 2021 Jul 26;19(3):394-400. doi: 10.1080/2090598X.2021.1954414. eCollection 2021.

    PubMed 34552791
  • Cottrell AM, Schneider MP, Goonewardene S, Yuan Y, Baranowski AP, Engeler DS, Borovicka J, Dinis-Oliveira P, Elneil S, Hughes J, Messelink BJ, de C Williams AC. Benefits and Harms of Electrical Neuromodulation for Chronic Pelvic Pain: A Systematic Review. Eur Urol Focus. 2020 May 15;6(3):559-571. doi: 10.1016/j.euf.2019.09.011. Epub 2019 Oct 19.

    PubMed 31636030
  • Mahran A, Baaklini G, Hassani D, Abolella HA, Safwat AS, Neudecker M, Hijaz AK, Mahajan ST, Siegel SW, El-Nashar SA. Sacral neuromodulation treating chronic pelvic pain: a meta-analysis and systematic review of the literature. Int Urogynecol J. 2019 Jul;30(7):1023-1035. doi: 10.1007/s00192-019-03898-w. Epub 2019 Mar 14.

    PubMed 30874835
  • Grinberg K, Weissman-Fogel I, Lowenstein L, Abramov L, Granot M. How Does Myofascial Physical Therapy Attenuate Pain in Chronic Pelvic Pain Syndrome? Pain Res Manag. 2019 Dec 12;2019:6091257. doi: 10.1155/2019/6091257. eCollection 2019.

    PubMed 31915499
  • Tam J, Loeb C, Grajower D, Kim J, Weissbart S. Neuromodulation for Chronic Pelvic Pain. Curr Urol Rep. 2018 Mar 26;19(5):32. doi: 10.1007/s11934-018-0783-2.

    PubMed 29582185

Questions about this trial

What is this clinical trial studying?

A study testing TENS and Myofascial trigger point release in people with Chronic Pelvic Pain and Myofascial Trigger Point 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 3 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: status not confirmed, as of the sponsor's last update on 10 May 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?

Results are not available in the source record.

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

Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NPRS (Numeric Pain Rating Scale) (time frame: 4 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 NCT05851742, which also lists 18 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 10 May 2023.

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