NCT05893290

Brief Summary

Exercise interventions are deemed essential for the effective management of patients with pain. Various therapy methods have been shown in the literature for pain and coping with pain. However, there is no study investigating the effectiveness of Basic Body Awareness Therapy in pain and coping with pain. In this respect, our study will contribute to the literature. The aim of our study is to compare the effectiveness of Basic Body Awareness Therapy and Therapeutic Exercises on pain coping strategies of Postmenopausal women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started May 2023

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

October 4, 2024

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

May 30, 2023

Last Update Submit

October 3, 2024

Conditions

Keywords

Postmenopausal womenBasic body awareness therapyPain coping

Outcome Measures

Primary Outcomes (5)

  • Body Awareness Questionnaire (BAQ)

    Body awareness of the participants will be evaluated Body Awareness Questionnaire (BAQ) developed by Shields, Mallory \& Simon. BAQ is a questionnaire that aims to determine the normal or abnormal sensitivity level of body composition. It consists of four subgroups (Attention to changes in body process and responses, sleep-wake cycle, prediction at onset of illness, prediction of body responses) and a total of 18 statements. The participant will be asked to rate each statement with numbers from one to seven (1 = not at all true for me, 7 = completely true for me). Rating in the survey is done as a total score. It is concluded that the higher the total score to be obtained from the questionnaire, the better the body awareness.

    3 minutes

  • McGill-Short Form Pain Questionnaire

    The pain levels of the PmW will be measured with the Short Form McGill Pain Questionnaire. The questionnaire, developed by Melzack in 1987 and the validity and reliability of the Turkish version of which was demonstrated in 2007, is widely used in measuring pain. This questionnaire consists of a total of 15 descriptive words to determine the sensory (11 words) and affective (4 words) dimensions of pain. In this section, the severity of pain (0=absent, 1=mild, 2=moderate, 3=severe) is evaluated. In addition, the pain felt at the time of measurement is measured with the Visual Analogue Scale (VAS) and the total pain intensity is measured with a 10-point Likert scale. On this scale, 1 = no pain, 10 = unbearable pain.

    5 minutes

  • Pain Coping Strategies

    Pain coping strategies of PmW will be assessed with Pain Coping Inventory (PCI). The scale developed by Kraaimaat and Evers evaluates how often chronic pain patients use behavioral and cognitive methods to cope with pain. The original form of the scale includes six dimensions as pain transformation, distraction, reducing demands, retreating, worrying, and resting. Pain transformation, comforting thinking, and distraction are active coping methods; retreat, worrying, and resting are passive coping methods. The scoring options range from 1 (almost none) to 4 (very often).

    5 minutes

  • Oswestry Low Back Pain Disability Index

    The Oswestry low back pain disability index (OLBPDI), first published in 1980, was developed to assess pain-related disability in people with acute, subacute, or chronic low back pain. It includes 1 item related to pain and 9 items related to activities of daily living (personal care, lifting, walking, sitting, standing, sleeping, social life and travel). Each item is measured on a 6-point ranking scale from best to worst-case scenario. A total score of 0-4 indicates no disability, 5-14 indicates mild disability, 15-24 indicates moderate disability, 25-34 indicates severe functional disability, and 35-50 indicates full functional disability.

    5 minutes

  • Neck Disability Index

    The questionnaire, which evaluates subjective symptoms and activities of daily living, consists of 10 sections (pain severity, lifting weights, sleep, reading, driving, headache, concentration, work life, personal care, and leisure activities). For each section, there are 6 items ranging from 0-5 points. The total score ranges from 0 to 50 (0: no excuse; 50: maximum excuse). The total score obtained from the questionnaire expresses the severity of neck disability (0-4 points no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability, and over 35 points total disability).

    5 minutes

Study Arms (3)

Therapeutic Exercise Group

ACTIVE COMPARATOR

The therapeutic exercise protocol will be taught to patients in the first session and will be done 3 times a week for 12 weeks.

Other: Therapeutic Exercise Group

Therapeutic Exercise+Basic Body Awareness (BBAT) Group

EXPERIMENTAL

This group will receive BBAT as well as therapeutic exercises for 3 times a week for 12 week. Therapeutic exercises will include strengthening, stretching, and stabilization exercises. BBAT will include postural alignment, breathing, and cognitive exercises.

Other: Therapeutic Exercise+Basic Body Awareness Therapy Group

Control Group

NO INTERVENTION

This group will not receive any treatment.

Interventions

Therapeutic exercise sessions will begin with a short educational talk that provides information on proper body mechanics, and the benefits of exercise, followed by simple warm-ups and three different stretching and five different strengthening exercises that emphasize hip, abdominal, and back muscles. The frequency of repetitions of each stretching and strength exercise will be 10 with a holding time of 10 sec. Each set of strengthening exercises will be followed by a different set of stretching exercises. Sessions will end with a short unguided period of deep slow breathing.

Therapeutic Exercise Group

This group will receive BBAT as well as therapeutic exercises. Therapeutic exercises will include strengthening, stretching, and stabilization exercises. BBAT will include postural alignment, breathing, and cognitive exercises.

Therapeutic Exercise+Basic Body Awareness (BBAT) Group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic lower back or neck pain lasting at least six months
  • Gone through the menopausal transition naturally within the last year
  • Not received a physiotherapy approach for pain management in the last six months
  • Be able to read and write in Turkish.

You may not qualify if:

  • Presence of significant neurological disorders
  • Presence of serious mental and psychological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cyprus Science University

Girne, TRNC, 99320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainNeck Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Beliz Belgen Kaygisiz, PT, PhD

    European University of Lefke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 7, 2023

Study Start

May 31, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

October 4, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations