Effects of Myofascial Release and Electrical Stimulation in Chronic Pelvic Pain

NCT05851742 | Unknown

• 1 other identifier: REC/RCR & AHS/23/0507
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Pelvic Pain; Myofascial Trigger Point Pain

Keywords

chronic pelvic pain syndrome; pelvic floor physical therapy; myofascial release; myofascial trigger points

Outcome Measures

Primary Outcomes (3)

• 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.

  4 weeks

• 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.

  4 weeks

• 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.

  4 weeks

Study Arms (2)

Mfofascial release with electrical stimulation

ACTIVE COMPARATOR

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

Device: TENS

Myofascial release without electrical stimulation

EXPERIMENTAL

Release of trigger points

Other: Myofascial trigger point release

Interventions

TENS DEVICE

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

Mfofascial release with electrical stimulation

Myofascial trigger point release OTHER

Release of trigger points

Myofascial release without electrical stimulation

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah Hospital Lahore

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (18)

• 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.

  PMID: 34476302 BACKGROUND

• 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.

  PMID: 33991702 BACKGROUND

• 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.

  PMID: 28261683 BACKGROUND

• 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.

  PMID: 28049214 BACKGROUND

• 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.

  PMID: 29757068 BACKGROUND

• 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.

  PMID: 31453525 BACKGROUND

• 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.

  PMID: 28458478 BACKGROUND

• 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.

  PMID: 35389057 BACKGROUND

• 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.

  PMID: 36513896 BACKGROUND

• 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.

  PMID: 34082473 BACKGROUND

• 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.

  PMID: 34552791 BACKGROUND

• 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.

  PMID: 31636030 BACKGROUND

• 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.

  PMID: 30874835 BACKGROUND

• 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.

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• 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.

  PMID: 29582185 BACKGROUND

• 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.

  PMID: 35918696 BACKGROUND

• 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.

  PMID: 34699406 BACKGROUND

• 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.

  PMID: 31587480 BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Hafiza Mehjabeen, MSWHPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: May 10, 2023
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)