search
Back to results

Effects of Myofascial Release and Electrical Stimulation in Chronic Pelvic Pain

Primary Purpose

Chronic Pelvic Pain, Myofascial Trigger Point Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
TENS
Myofascial trigger point release
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain focused on measuring chronic pelvic pain syndrome, pelvic floor physical therapy, myofascial release, myofascial trigger points

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jinnah Hospital LahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mfofascial release with electrical stimulation

Myofascial release without electrical stimulation

Arm Description

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

Release of trigger points

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2023
Last Updated
May 9, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05851742
Brief Title
Effects of Myofascial Release and Electrical Stimulation in Chronic Pelvic Pain
Official Title
Effects of Myofascial Release With and Without Electrical Stimulation on Pain and Functionality in Women With Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain, Myofascial Trigger Point Pain
Keywords
chronic pelvic pain syndrome, pelvic floor physical therapy, myofascial release, myofascial trigger points

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mfofascial release with electrical stimulation
Arm Type
Active Comparator
Arm Description
TENS 50-280 HZ frequency and a pulse duration of 50 us for 10 minutes along with 10 minutes myofascial release.
Arm Title
Myofascial release without electrical stimulation
Arm Type
Experimental
Arm Description
Release of trigger points
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
TENS 50-280 HZ frequency and a pulse duration of 50 us for 10 minutes along with 10 minutes myofascial release.
Intervention Type
Other
Intervention Name(s)
Myofascial trigger point release
Intervention Description
Release of trigger points
Primary Outcome Measure Information:
Title
NPRS (Numeric Pain Rating Scale)
Description
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.
Time Frame
4 weeks
Title
FPPS (Functional Pelvic Pain Scale)
Description
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.
Time Frame
4 weeks
Title
PFIQ-7 (Pelvic Floor Impact Questionaire)
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, MSWHPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital Lahore
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, MSWHPT
Phone
03026577666
Email
mehjabeen@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Sitara Farasat, DPT
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, MSWHPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34476302
Citation
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.
Results Reference
background
PubMed Identifier
33991702
Citation
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.
Results Reference
background
PubMed Identifier
28261683
Citation
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.
Results Reference
background
PubMed Identifier
28049214
Citation
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.
Results Reference
background
PubMed Identifier
29757068
Citation
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.
Results Reference
background
PubMed Identifier
31453525
Citation
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.
Results Reference
background
PubMed Identifier
28458478
Citation
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.
Results Reference
background
PubMed Identifier
35389057
Citation
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.
Results Reference
background
PubMed Identifier
36513896
Citation
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.
Results Reference
background
PubMed Identifier
34082473
Citation
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.
Results Reference
background
PubMed Identifier
34552791
Citation
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.
Results Reference
background
PubMed Identifier
31636030
Citation
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.
Results Reference
background
PubMed Identifier
30874835
Citation
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.
Results Reference
background
PubMed Identifier
31915499
Citation
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.
Results Reference
background
PubMed Identifier
29582185
Citation
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.
Results Reference
background
PubMed Identifier
35918696
Citation
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.
Results Reference
background
PubMed Identifier
34699406
Citation
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.
Results Reference
background
PubMed Identifier
31587480
Citation
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.
Results Reference
background

Learn more about this trial

Effects of Myofascial Release and Electrical Stimulation in Chronic Pelvic Pain

We'll reach out to this number within 24 hrs