Effectiveness of Manual Therapy in Dysmenorrhea

NCT03593057 | Completed

• 1 other identifier: ID0023
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this clinical study would be to verify if manual therapy is effective in the treatment to reduce pain in women suffering from primary dysmenorrhea. Material and methods In this experimental study, women diagnosed with primary dysmenorrhea will be included, which will be divided randomly into two groups: an intervention group and a comparator group. The study will last nine weeks (3 menstrual cycles). Patients in the intervention group will receive 3 treatment sessions. The evaluation will include pain, the quality of life, the global impression of change, personal body satisfaction and global self-perception and the pain perception.

Conditions

Dysmenorrhea Primary

Keywords

dysmenorrhoea; manual therapy

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale of Pain.

  The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.

  9 weeks

Secondary Outcomes (4)

• SF-36 quality of life scale.

  9 weeks

• Global Impression Change Scale.

  9 weeks

• Body Satisfaction and global self-perception Questionnaire.

  9 weeks

• McGill pain perception questionnaire.

  9 weeks

Study Arms (2)

Manual therapy protocol

EXPERIMENTAL

Manual therapy protocol and self-care advice and body awareness. Three sessions of manual therapy will be applied, (at the beginning, at 2 weeks and at 3 weeks).

Other: Control group

Control group.

ACTIVE COMPARATOR

Advice on self-care and body awareness.

Other: Manual therapy

Interventions

Manual therapy OTHER

Manual therapy protocol and self-care advice and body awareness.

Control group.

Control group OTHER

Advice on self-care and body awareness.

Manual therapy protocol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women with dysmenorrhoea
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with menstrual pain of more than 6 months of evolution.
• Women with pain equal to or greater than 4 on the visual analogue scale in more than half of their one-year menstrual cycles.

You may not qualify if:

• Hormone treatment
• Contraindication to any of the treatments
• Participate in this period of no functional recovery program or physiotherapy treatment.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (2)

Faculty of Physiotherapy

Valencia, 46010, Spain

Location

Gemma V Espí López

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Musculoskeletal Manipulations; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: July 19, 2018
• Study Start: June 5, 2018
• Primary Completion: July 31, 2018
• Study Completion: August 31, 2018
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

ES (2)