The Effects of Connective Tissue Manipulation in Primary Dysmenorrhea

NCT03914014 | Completed

• 1 other identifier: 2018-158
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: The aim of the present study is to investigate the efficacy of connective tissue massage in patients with primary dysmenorrhea. The present study is designed as a randomized placebo controlled study. Patients with primary dysmenorrhea and who agreed to participate in the study will be randomly divided into three groups. Connective tissue massage will be applied to the patients in the intervention group. Placebo ultrasound treatment will be applied to the patients in the placebo group. No application will be applied to the patients in the control group. As the research design includes the placebo group and the control group, it will be determined that if significant differences between the intervention and placebo groups are observed, this treatment effect is not related to a placebo effect or is not due to the natural course of the disease. If significant differences are found, the efficacy of the connective tissue manipulation in primary dysmenorrhea will be revealed and connective tissue manipulation may be an alternative approach to pharmacological approaches and other commonly used applications. This may reduce the need for pharmacological agents and reduce or eliminate the side effects associated with these agents. According to the literature, there are studies that investigate short-term effects of connective tissue massage on symptoms of primary dysmenorrhea and quality of life. However, there is no long-term follow-up randomized placebo-controlled study investigating the effect of connective tissue massage on menstrual pain and symptoms.

Conditions

Primary Dysmenorrhea

Keywords

connective tissue massage; massage; menstrual pain; treatment

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity will be assessed by 0-10 cm Visual Analogue Scale. The score ranges between 0 and 10. Higher scores indicate higher pain intensity.

  change from baseline pain intensity to 6 months

Secondary Outcomes (3)

• Anxiety level

  change from baseline anxiety level to 6 months

• Psychological status

  change from baseline psychological status to 6 months

• Self-reported improvement

  change from baseline self-reported improvement to 6 months

Study Arms (3)

intervention

ACTIVE COMPARATOR

connective tissue manipulation

Other: connective tissue manipulation

placebo ultrasound

PLACEBO COMPARATOR

placebo ultrasound

Other: placebo ultrasound

control

NO INTERVENTION

control group

Interventions

connective tissue manipulation OTHER

From the estimated date of ovulation to the onset of menstrual bleeding, connective tissue massage will be applied to the sacral, lumbar, lower thoracic and anterior pelvic regions for 5 days per week. The application will take 10 min. During the massage treatment, the physiotherapist will touch the end of the middle finger with the skin of the patient and apply the skin to the pull. The patient will be in the supine position during the treatment of the anterior pelvic region while the patient is in the sitting position during the treatment of the back area.

intervention

placebo ultrasound OTHER

From the estimated date of ovulation to the beginning of the next menstrual bleeding, placebo ultrasound will be applied a total of 10 minutes (5 minutes for sacral and lumbar, and lower thoracic regions and 5 min for the anterior pelvic region). Placebo ultrasound application will be performed with superficial circular movements without applying excessive pressure. During the application, the device will only be switched on, the dose will not be adjusted and the patient will be given an image of ultrasound dose.

placebo ultrasound

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being volunteer to participate in the study
• Having regular menstrual cycles (28 ± 7 days)
• Being nulliparous
• Having history of the onset of menstrual pain in the first few years after menarche
• Considering the last 6 months, pain intensity \>4 on the Visual Analog Scale.

You may not qualify if:

• Severe gastrointestinal, urogynecologic or autoimmune disease, other chronic pain syndromes, psychiatric disorder
• Pregnancy
• Use of intrauterine device
• Use of pharmacologic agents (except analgesics or non-NSAID) or non-pharmacological agent
• Urogynecological surgery
• Oral contraceptive or antidepressant use during the last 6 months
• Having an irregular menstrual cycle
• Endometriosis associated with suspected dysmenorrhea, pathologic condition associated with uterine pain such as fibroids, or ultrasonographic examination

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 9000, Turkey (Türkiye)

Location

Related Publications (4)

• Kannan P, Claydon LS. Some physiotherapy treatments may relieve menstrual pain in women with primary dysmenorrhea: a systematic review. J Physiother. 2014 Mar;60(1):13-21. doi: 10.1016/j.jphys.2013.12.003. Epub 2014 Apr 24.

  PMID: 24856936 RESULT

• Holey LA, Dixon J. Connective tissue manipulation: a review of theory and clinical evidence. J Bodyw Mov Ther. 2014 Jan;18(1):112-8. doi: 10.1016/j.jbmt.2013.08.003. Epub 2013 Sep 8.

  PMID: 24411158 RESULT

• Demirturk F, Erkek ZY, Alparslan O, Demirturk F, Demir O, Inanir A. Comparison of Reflexology and Connective Tissue Manipulation in Participants with Primary Dysmenorrhea. J Altern Complement Med. 2016 Jan;22(1):38-44. doi: 10.1089/acm.2015.0050. Epub 2015 Sep 18.

  PMID: 26382885 RESULT

• Ozgul S, Uzelpasaci E, Orhan C, Baran E, Beksac MS, Akbayrak T. Short-term effects of connective tissue manipulation in women with primary dysmenorrhea: A randomized controlled trial. Complement Ther Clin Pract. 2018 Nov;33:1-6. doi: 10.1016/j.ctcp.2018.07.007. Epub 2018 Jul 21.

  PMID: 30396605 RESULT

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ceren Gursen

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 12, 2019
• Study Start: May 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

TU (1)