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DyspareuniaNCT05834088

Effects of Myofascial Release With and Without Thiele Massage

A study testing Myofascial release techniques and Thiele massage in people with Dyspareunia and 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

Dysperunia is caused by chronic discomfort during sexual intercourse causing pain during vaginal intercourse.Sexual pain causes relationship decreasing quality of life following anxiety and depression.Myofascial techniques with and without Thiele massage will be used via randomised controlled trial following sample… Read more about this study

Who is it for?
Ages 23 to 40 years, women only
Conditions the study is for
Dyspareunia, Pain, Quality of Life
What is being tested?
Myofascial release techniques and Thiele massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 sitePakistan
Study dates
20 Nov 2022to 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 23 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 23-40
  • Dyspareunia symptoms for more than 6 months
  • Females with tenderness of pelvic muscles from last 6 months
  • Nulliparous women

Who cannot join

  • Any pelvic organ prolapse
  • Any current genital malignancy
  • Cases of chronic pelvic pain due to any other issue
  • Any traumatic conditions around the pelvis and lower limbs, any infectious, tumors conditions around the pelvis.
  • Pregnant females
  • Any lower limb abnormalities, any recently underwent abdominal and low back surgery.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Jinnah hospital

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effects of Myofascial Release With and Without Thiele Massage on Dyspareunia and Pelvic Floor Function in Nulliparous Females

Dysperunia is caused by chronic discomfort during sexual intercourse causing pain during vaginal intercourse.Sexual pain causes relationship decreasing quality of life following anxiety and depression.Myofascial techniques with and without Thiele massage will be used via randomised controlled trial following sample size of 38.

Read the detailed description

Dyspareunia is characterised by recurring or chronic discomfort during sexual intercourse that causes distress. Dyspareunia can be superficial, causing pain when vaginal insertion is tried, or profound. Women who experience sexual pain are more likely to experience sexual dysfunction, relationship distress, decreased quality of life, anxiety, and depression. One in five nulliparous women (a female who has never given birth to a baby) experiences moderate dyspareunia. Myofascial pain is typically treated using manual manipulation (Manual manipulation involves using skilled, hands-on maneuvers to perform soft tissue mobilization, myofascial release and more) or Thiele massage. In this study the aim is to find the individual and combined effect of these techniques. The study will be Randomized Controlled Trial (RCT). Non probabiity convenient sampling technique will be used to assign randomly half of patients in group A for the experimental group and half in group B who will meet the inclusion criteria. Group A will include participants who will receive myofascial releases and Thiele massage. Whereas Group B will include participants who will receive myofascial releasing techniques but not Thiele massage.

Both group will have 1 session per week for 12 weeks. Numeric pain rating scale, Female sexual function index, Functional pelvic pain scale would be used as an outcome measure tools.

The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25

Being tested
Myofascial release techniques, Thiele massage
Keywords
Dyspareunia, Pelvic floor disorder, Pelvic pain, Myofascial release technique, Pelvic floor
Medical subject headings
Dyspareunia, Pain, Pelvic Floor Disorders, Pelvic Pain

What participants receive

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

  • Myofascial release techniquesOther

    12 treatment sessions will be given in 12 weeks

  • Thiele massageOther

    12 treatment sessions will be given in 12 weeks

Study groups in NCT05834088
Study groupRoleWhat they receive
Myofascial techniques with Thiele massageExperimentalGroup A will receive myofascial techniques with Thiele massage. 12 treatment sessions will be given in 12 weeks
Receives: Other: Myofascial release techniques; Other: Thiele massage
Myofascial techniques without Thiele massageActive comparatorGroup B will receive myofascial techniques without Thiele massage. 12 treatment sessions will be given in 12 weeks
Receives: Other: Myofascial release techniques

What is being measured

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

  1. Numeric pain rating scale

    The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

    Measured: 12 weeks

  2. Female sexual function index

    The FSFI is a widely-used measure of Female Sexual Dysfunction (FSD). It assesses 6 domains: desire; arousal; lubrication; orgasm; satisfaction; and pain.

    Measured: 12 weeks

  3. Functional pelvic pain scale

    Functional Pelvic Pain Scale (FPPS), designed to measure pelvic pain intensity as it relates to functions of daily living (bladder and bowel function, intercourse, walking, running, lifting, working, and sleeping).

    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 Apr 2023
  2. Study start20 Nov 2022
  3. Primary completion30 Jul 2023
  4. Study completion1 Aug 2023

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
Single blind
Who is masked
Participant
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05834088
Sponsor's protocol ID
REC/RCR & AHS/23/0513
Status last verified
Jun 2024
First submitted
18 Apr 2023
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mitchell KR, Geary R, Graham CA, Datta J, Wellings K, Sonnenberg P, Field N, Nunns D, Bancroft J, Jones KG, Johnson AM, Mercer CH. Painful sex (dyspareunia) in women: prevalence and associated factors in a British population probability survey. BJOG. 2017 Oct;124(11):1689-1697. doi: 10.1111/1471-0528.14518. Epub 2017 Jan 25.

    PubMed 28120373

  • Carlson K, Mikes BA. Dyspareunia. 2026 Jan 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562159/

    PubMed 32965830

  • Castellanos-Lopez E, Castillo-Merino C, Abuin-Porras V, Lopez-Lopez D, Romero-Morales C. Ultrasonography Comparison of Pelvic Floor and Abdominal Wall Muscles in Women with and without Dyspareunia: A Cross-Sectional Study. Diagnostics (Basel). 2022 Jul 29;12(8):1827. doi: 10.3390/diagnostics12081827.

    PubMed 36010178

  • Rosen NO, Dawson SJ, Binik YM, Pierce M, Brooks M, Pukall C, Chorney J, Snelgrove-Clarke E, George R. Trajectories of Dyspareunia From Pregnancy to 24 Months Postpartum. Obstet Gynecol. 2022 Mar 1;139(3):391-399. doi: 10.1097/AOG.0000000000004662.

    PubMed 35115480

  • Alimi Y, Iwanaga J, Oskouian RJ, Loukas M, Tubbs RS. The clinical anatomy of dyspareunia: A review. Clin Anat. 2018 Oct;31(7):1013-1017. doi: 10.1002/ca.23250. Epub 2018 Oct 26.

    PubMed 30113086

  • Geller EJ, Babb E, Nackley AG, Zolnoun D. Incidence and Risk Factors for Pelvic Pain After Mesh Implant Surgery for the Treatment of Pelvic Floor Disorders. J Minim Invasive Gynecol. 2017 Jan 1;24(1):67-73. doi: 10.1016/j.jmig.2016.10.001. Epub 2016 Oct 20.

    PubMed 27773810

Questions about this trial

What is this clinical trial studying?

A study testing Myofascial release techniques and Thiele massage in people with Dyspareunia and 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 4 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 13 Jun 2024. 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?

Numeric pain rating 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 NCT05834088, which also lists 6 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 13 Jun 2024.

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