Effects of Myofascial Release and Electrical Stimulation in Chronic Pelvic Pain

NCT ID: NCT05851742

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pelvic Pain Myofascial Trigger Point Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mfofascial release with electrical stimulation

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

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

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

Myofascial release without electrical stimulation

Release of trigger points

Group Type EXPERIMENTAL

Myofascial trigger point release

Intervention Type OTHER

Release of trigger points

Interventions

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TENS

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

Intervention Type DEVICE

Myofascial trigger point release

Release of trigger points

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Prolapse of the pelvic organ,
* Pregnency,
* Fibromyalgia
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hafiza Mehjabeen, MSWHPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Jinnah Hospital Lahore

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Imran Amjad, Phd

Role: CONTACT

03324390125

Facility Contacts

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Hafiza Mehjabeen, MSWHPT

Role: primary

03026577666

References

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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 33991702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28261683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28049214 (View on PubMed)

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.

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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.

Reference Type BACKGROUND
PMID: 28458478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35389057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36513896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34082473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34552791 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31636030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30874835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31915499 (View on PubMed)

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.

Reference Type BACKGROUND
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Baltazar MCDV, Russo JAO, De Lucca V, Mitidieri AMS, da Silva APM, Gurian MBF, Poli-Neto OB, Rosa-E-Silva JC. Therapeutic ultrasound versus injection of local anesthetic in the treatment of women with chronic pelvic pain secondary to abdominal myofascial syndrome: a randomized clinical trial. BMC Womens Health. 2022 Aug 2;22(1):325. doi: 10.1186/s12905-022-01910-y.

Reference Type BACKGROUND
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Modarresi S, Lukacs MJ, Ghodrati M, Salim S, MacDermid JC, Walton DM; CATWAD Consortium Group. A Systematic Review and Synthesis of Psychometric Properties of the Numeric Pain Rating Scale and the Visual Analog Scale for Use in People With Neck Pain. Clin J Pain. 2021 Oct 26;38(2):132-148. doi: 10.1097/AJP.0000000000000999.

Reference Type BACKGROUND
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Plavnik K, Tenaglia A, Hill C, Ahmed T, Shrikhande A. A Novel, Non-opioid Treatment for Chronic Pelvic Pain in Women with Previously Treated Endometriosis Utilizing Pelvic-Floor Musculature Trigger-Point Injections and Peripheral Nerve Hydrodissection. PM R. 2020 Jul;12(7):655-662. doi: 10.1002/pmrj.12258. Epub 2019 Nov 15.

Reference Type BACKGROUND
PMID: 31587480 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/23/0507

Identifier Type: -

Identifier Source: org_study_id

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