Effects of Connective Tissue Manipulation on Menopausal Symptoms

NCT05293860 | Completed

• 1 other identifier: 499
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. This process involves some bothersome physical and psychological climacteric symptoms. The most common symptoms are vasomotor symptoms, psychological symptoms and sleep disturbances. The aim of this study is to investigate the effects of CTM on postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia. For this purpose, 58 postmenopausal women who meet the inclusion criteria and volunteer to participate in the study will be randomly assigned to one of the two research arms; CTM or sham control. The participants in the experimental group will receive CTM for 5-20 minutes, 3 times a week for 4 weeks, whereas the participant in the sham control group will receive superficial massage with the head of the therapeutic ultrasound device for 15 minutes at the same frequency for 4 weeks. In this study, primary outcome is menopausal symptom severity and will be assessed by the \"Menopause Rating Scale\". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires; \"Menopause-Specific Quality of Life Scale\", \"Depression-Anxiety-Stress 21 Scale\" and \"Insomnia Severity Index\". All outcome measurements will be evaluated at baseline and after the intervention period. Then, the results will be compared within groups and between two study groups.

Conditions

Menopause Syndrome

Keywords

Menopause; Vasomotor symptom; Massage; Connective tissue massage; Connective tissue manipulation; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Severity of menopausal symptoms

  The severity of menopausal symptoms will be evaluated with the Menopause Rating Scale (MRS). MRS was developed to assess the severity of 11 symptoms associated with menopause. Each of the 11 symptoms may score between 0 (no symptoms) and 4 points (severe symptoms), depending on the perceived severity of the complaints. The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints).

  Change in the severity of menopausal symptoms from baseline to at the end of the 4th week.

Secondary Outcomes (5)

• Frequency of vasomotor symptoms

  Change in the frequency of vasomotor symptoms from baseline to at the end of the 4th week.

• Vasomotor symptom intensity

  Change in the vasomotor symptom score from baseline to at the end of the 4th week.

• Quality of life associated with menopause

  Change in quality of life associated with menopause from baseline to at the end of the 4th week.

• Level of psychological symptoms

  Change in the level of psychological symptoms from baseline to at the end of the 4th week.

• Severity of insomnia

  Change in severity of insomnia from baseline to at the end of the 4th week.

Other Outcomes (1)

• Intervention Satisfaction

  Satisfaction with CTM and with placebo therapeutic ultrasound is compared at the end of the 4th week.

Study Arms (2)

Connective tissue manipulation

EXPERIMENTAL

Connective tissue manipulation will be applied to participants' back for 5-20 minutes, 3 times a week for 4 weeks in this group.

Other: Connective tissue manipulation

Superficial massage with the head of the therapeutic ultrasound device

SHAM COMPARATOR

Superficial massage with the head of the therapeutic ultrasound device will be applied to participants' back for 15 minutes, 3 times a week for 4 weeks in this group.

Other: Superficial massage with the head of the therapeutic ultrasound device

Interventions

Connective tissue manipulation OTHER

Connective tissue manipulation will be applied to participants' back for 5-20 minutes, 3 times a week for 4 weeks in this group.

Connective tissue manipulation

Superficial massage with the head of the therapeutic ultrasound device OTHER

Superficial massage with the head of the therapeutic ultrasound device will be applied to participants' back for 15 minutes, 3 times a week for 4 weeks in this group.

Superficial massage with the head of the therapeutic ultrasound device

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between the 45 and 65 years,
• Being experienced at least 3 moderate or severe hot flashes, sweating or night sweats per day for at least 3 months,
• Being in the natural/spontaneous postmenopausal (amenorrhea for at least 12 months) period for less than 10 years,
• Having stable vital signs (heart rate, blood pressure),
• Volunteer to participate in the study,
• Have signed the informed consent form.

You may not qualify if:

• Neurological diseases,
• Uncontrolled systemic and metabolic diseases (uncontrolled diabetes mellitus, hypertension, etc.)
• History of cancer,
• History of surgical menopause,
• Obesity (BMI \> 35 kg/m²),
• Use of any hormonal or non-hormonal treatment for vasomotor or other menopausal symptoms in the past 6 months,
• Psychiatric and mental disorders that prevent the cooperation to the study.

Sponsors & Collaborators

• Hacettepe University: lead
• Hitit University: collaborator

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (12)

• Gracia CR, Freeman EW. Onset of the Menopause Transition: The Earliest Signs and Symptoms. Obstet Gynecol Clin North Am. 2018 Dec;45(4):585-597. doi: 10.1016/j.ogc.2018.07.002. Epub 2018 Oct 25.

  PMID: 30401544 BACKGROUND

• Roberts H, Hickey M. Managing the menopause: An update. Maturitas. 2016 Apr;86:53-8. doi: 10.1016/j.maturitas.2016.01.007. Epub 2016 Jan 22.

  PMID: 26921929 BACKGROUND

• Santoro N, Epperson CN, Mathews SB. Menopausal Symptoms and Their Management. Endocrinol Metab Clin North Am. 2015 Sep;44(3):497-515. doi: 10.1016/j.ecl.2015.05.001.

  PMID: 26316239 BACKGROUND

• Cobin RH, Goodman NF; AACE Reproductive Endocrinology Scientific Committee. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY POSITION STATEMENT ON MENOPAUSE-2017 UPDATE. Endocr Pract. 2017 Jul;23(7):869-880. doi: 10.4158/EP171828.PS.

  PMID: 28703650 BACKGROUND

• 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 BACKGROUND

• Fu P, Gibson CJ, Mendes WB, Schembri M, Huang AJ. Anxiety, depressive symptoms, and cardiac autonomic function in perimenopausal and postmenopausal women with hot flashes: a brief report. Menopause. 2018 Dec;25(12):1470-1475. doi: 10.1097/GME.0000000000001153.

  PMID: 29916944 BACKGROUND

• Guttuso T Jr, DiGrazio WJ, Reddy SY. Review of hot flash diaries. Maturitas. 2012 Mar;71(3):213-6. doi: 10.1016/j.maturitas.2011.12.003. Epub 2012 Jan 9.

  PMID: 22230663 BACKGROUND

• Schneider HP, Heinemann LA, Rosemeier HP, Potthoff P, Behre HM. The Menopause Rating Scale (MRS): reliability of scores of menopausal complaints. Climacteric. 2000 Mar;3(1):59-64. doi: 10.3109/13697130009167600.

  PMID: 11910611 BACKGROUND

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 BACKGROUND

• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

  PMID: 21532953 BACKGROUND

• Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.

  PMID: 8844630 BACKGROUND

• Albayrak G, Cagliyan Turk A, Ozgul S. Effects of connective tissue massage on physical and emotional symptoms, insomnia, and quality of life in postmenopausal women: A randomized, sham-controlled trial. Maturitas. 2025 Jan;191:108149. doi: 10.1016/j.maturitas.2024.108149. Epub 2024 Nov 7.

  PMID: 39522476 DERIVED

Study Officials

• Serap Özgül, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: April 15, 2022
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: September 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)