The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea

NCT04509934 | Completed

• 1 other identifier: 12
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to reveal the effects of connective tissue manipulation (CTM) on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms.

Conditions

Primary Dysmenorrhea

Keywords

primary dysmenorrhea; pain; women; connective tissue manipulation; longterm follow up

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale

  Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."

  baseline (first assessment) and 3th, 6th and 12th months after treatment

• Visual Analogue Scale

  Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."

  3th month after treatment

• Visual Analogue Scale

  Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."

  6th month after treatment

• Visual Analogue Scale

  Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."

  12th month after treatment

Secondary Outcomes (24)

• Visual Analogue Scale

  baseline (first assessment)

• Visual Analogue Scale

  3th month after treatment

• Visual Analogue Scale

  6th month after treatment

• Visual Analogue Scale

  12th month after treatment

• Visual Analogue Scale

  baseline (first assessment)

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Connective Tissue Manipulation was performed to participants in Group 1, starting at the end of the menstrual cycle, 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period.

Other: Connective Tissue Manipulation

Group 2

ACTIVE COMPARATOR

In Group 2, Connective Tissue Manipulation was started with the completion of menstrual cycle performed to participants for 5 days a week and until the other menstrual cycles. At the end of the menstrual cycle, it was restarted and a total of 2 cycles were applied until the second menstrual cycle started (approximately 6 weeks).

Other: Connective Tissue Manipulation

Interventions

Connective Tissue Manipulation OTHER

The position of the patients during treatment sessions was sitting with the hips and knees at 90° flexion and feet supported, arms relaxed on the thighs, back naked and straight, allowing optimal tension of the connective tissue. The CTM procedure consisted of treating 3 sections in the back. These sections were basic (sacral and lumbar regions), lower thoracic (L1 through T7) and anterior pelvic. All sessions were ended with bilateral long strokes to the iliac crest and subcostal regions. The physiotherapist applied strokes bilaterally by her middle finger of the right or left hand to the defined zones of the mentioned sections in the back. The treatment started from the basic section, and progress to other regions was decided according to the vascular reaction of the connective tissue. Each session lasted for 5 to 20 minutes, depending on the extent of the treated area.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being in a age range 18-30
• Diagnosed with Primary Dysmenorrhea by a gynecologist
• Having a regular menstrual cycle (28±7 days)
• Being nulliparous
• Having menstrual pain intensity above 5cm according to Visual Analog Scale

You may not qualify if:

• Having gastrointestinal, urogynecologic, or psychiatric disease, other chronic pain syndromes
• Having a positive pregnancy test
• History of pelvic surgery
• Usage of oral contraceptives or antidepressants for at least 3 months
• Having irregular menstrual cycles (defined as lasting\<21or\>35 days)
• Having a history or an ultrasonographic observation of pathological conditions indicating secondary dysmenorrhea

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Pamukkale University: collaborator

Study Sites (1)

Pamukkale University

Denizli, 20000, Turkey (Türkiye)

Location

Related Publications (1)

• Yagci N, Senel A, Atalay OT, Akman TC, Can OK. Long-Term Follow-Up Result of Connective Tissue Manipulation in Young Women with Primary Dysmenorrhea: Different Intervention Durations. Reprod Sci. 2023 Jul;30(7):2198-2209. doi: 10.1007/s43032-023-01172-5. Epub 2023 Jan 30.

  PMID: 36717461 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nesrin Yağcı, PT, Prof

  Pamukkale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analyses will be performed by the statistics specialist that does not know anything about the methodology of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Sub-investigator, Physiotherapist, MSc

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: August 12, 2020
• Study Start: July 30, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)