The Effect on Back Pain and Fatigue Level of Acupressure

March 12, 2024 updated by: Birgul Vural Dogru, Mersin University

The Effect on Back Pain and Fatigue Level of Acupressure After Coronary Angiography: A Randomized, Single-Blind Sham-Controlled Study

This research was conducted with the aim of determining the effect of acupressure on the level of back pain and fatigue after coronary angiography.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To prevent bleeding, hematoma, and embolism after coronary angiography, patients are asked to stay in bed for 6 to 24 hours. During complete bed rest for at least 6 hours, the patient should keep his/her feet flat. The patient should lie in the supine position and avoid rapid movements. Long-term bed rest (at least 6 hours) in post-angiographic patients causes weakening of the lower back muscles and fatigue due to the pressure constantly applied to the same muscles, while muscle fatigue causes muscle spasms and lower back pain. Today, acupressure is also used along with various pharmacological treatments to relieve pain and fatigue.

Acupressure is a massage technique that ensures the proper functioning of energy channels by applying some pressure to certain parts of the body with the thumbs or index fingers, hands, palms, wrists and knees for therapeutic purposes. Acupressure points are the same as acupuncture points. Although there is no needle inserted into the body as in acupuncture.

According to G-power analysis, the total number of samples was calculated as 120.

A total of 120 participants will be randomly assigned to the acupuncture group (n=40), sham acupuncture group (n=40) and control group (n=40).

A Personal Information Form and Visual Analog Scales for Pain and Fatigue will be used to collect data.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mersin, Turkey, 33110
        • Recruiting
        • Birgül VURAL DOĞRU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Planned coronary angiography from the femoral region
  • Not diagnosed with low back pain
  • No stent or other interventional procedure was performed during the coronary angiography procedure.

Exclusion Criteria:

  • Those who have had acupressure before for any purpose
  • Problems such as bleeding and dysrhythmia occur after coronary angiography,
  • Those with burns, scars, scratches and deformities at the acupressure point
  • Having any psychological disorder,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acupressure group

After coronary angiography, acupressure will be applied for a total of 15 minutes. For the acupressure group, a total of three points will be applied: the heart meridian 7th point (HT7), the large intestine meridian 4th point (LI4), and the stomach meridian 36th point (ST36), which is deemed appropriate in the lower extremity.

The symmetry of the three selected different points will also be applied to the other extremity.
Other: Acupressure

For the acupressure group, a total of three points will be applied: the heart meridian 7th point (HT7), the large intestine meridian 4th point (LI4), and the stomach meridian 36th point (ST36), which is deemed appropriate in the lower extremity The symmetry of the three selected different points will also be applied to the other extremity.

After coronary angiography, acupressure will be applied for a total of 15 minutes.
Placebo Comparator: Sham acupressure
In the acupressure application applied to the sham group, parallel pressure will be applied to the bone area and points where the HT7, LI4, ST36 meridians do not pass.
Other: Sham acupressure
In the acupressure application applied to the sham group, parallel pressure will be applied to the bone area and points where the HT7, LI4, ST36 meridians do not pass.
No Intervention: Control group
With the control group, no intervention was conducted, and only standard care was given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale for Pain
Time Frame: 1 year
It is used to measure subjectively perceived pain. On the scale, which includes the numbers between 0 and 10 cm, which are the most commonly used to determine the intensity of pain quantitatively, with painlessness at one end and the most severe pain possible at the other end, "0" defines painlessness and "10" defines the most severe pain.
1 year
Visual Analog Scale for Fatigue
Time Frame: 1 year

The fatigue scale is a 10 cm scale that evaluates the severity of fatigue ranked from 0 to 10.

On the left side of the scale, there is a rating of "I do not feel tired", and on the right side, there is a rating of "I feel extreme fatigue and exhaustion".
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-HF-BVD-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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