Pain Education Added to Conventional Physiotherapy Program for Patients With Neck Pain

Purpose: The aim of this study is to examine the effects of pain training applied with conventional physiotherapy on pain, range of motion, disability, kinesiophobia and quality of life in patients with neck pain.

Methods: The research is planned to be completed within 18 months at Istanbul Hospital.

It is planned to include 40 individualsbetween the ages of 18-65 with neck pain persisting for 3 months or more.Individuals will be randomly divided into 2 groups.

Conventional physiotherapy program will be applied to the first group. Conventional physiotherapy will be applied to the second group and neuroscience education will be given.Pain intensity will evaluate before and after exercise with 'Visual Analog Scale' (VAS), and algometer,range of motion will evaluate with C-ROM, kinesiofobia will questioned with Tampa Kinesiofobia Score, Quality of life will evaluate with Nottingham Health Profile, whereas the level of neck disability will evaluate before and after exercise with 'Neck Pain and Disability Score' (NPDS). The obtained results will analyze using appropriate statistical methods.

Study Overview

• Status: Completed
• Conditions: Pain; Neck Pain
• Intervention / Treatment: Other: Conventional physiotherapy; Other: Neuroscience education

Detailed Description

The treatment program will be applied 3 days a week for 8 weeks.Each 2 groups; will be evaluated twice, at the beginning of the treatment and at the end of the 8th week.

Conventional physiotherapy program consists of neck isometric exercises, neck isotonic exercises, stabilization exercises, stretching exercises and posture exercises and physiotherapy agents.

Neuroscience education; The trainings will be conducted in the form of face-to-face interviews and 45-50 minute one-to-one sessions.

Posters, pictures, graphics and stories, as well as booklets and videos from Explain Pain, Pain in motion and retrainpain websites will be used in appropriate sessions.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Özden YAŞARER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• between the ages of 18-65
• neck pain that persists for 3 months or more

Exclusion Criteria:

• Patients undergoing cervical surgery
• Patients with neck pain secondary to neurological or vascular disease or neoplasia
• Patients with radiculopathy with neurological deficits
• Patients with a history of inflammatory or infective arthritis of the cervical spine
• Patients who received a physical therapy program in the last 6 months
• Patients with pain in the scapula, shoulder, upper extremity or lumbar region that may interfere with neck stabilization exercises

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conventional physiotherapy; Conventional physiotherapy program consists of neck isometric exercises, neck isotonic exercises, stabilization exercises, stretching exercises and posture exercises and physiotherapy agents.	Other: Conventional physiotherapy; Group 1 was given conventinal physiotherapy Physiotherapy agents; 5 min ultrasound 1.5 watts/cm2 20 min conventional TENS 20 min heat agent application (hot pack) Exercise program; Stretching and relaxation exercises, Neck strengthening exercises that include concentric and isometric contractions Posture exercises 3 sets per day, 1 in the hospital with 10 repetitions
Active Comparator: Neuroscience education; Conventional physiotherapy program and The neuroscience education trainings will be conducted in the form of face-to-face interviews and 45-50 minute one-to-one sessions.	Other: Neuroscience education; Conventional physiotherapy program and The neuroscience education trainings will be conducted in the form of face-to-face interviews and 45-50 minute one-to-one sessions. In sessions ; neurons and nerve conduction in the session, the formation process of pain, peripheral neuropathic pain, pain spread during the session, neuroplasticity, peripheral and central sensitization, hyperalgesia and allodynia, acute-chronic pain, The effects of stress, fear, anxiety, false thoughts and beliefs about pain and other psychosocial factors on the pain process and determining possible psychosocial factors in the patient during the session, Strategies for controlling the pain process and coping with psychosocial factors in the session will be completed by explaining the effect mechanisms of exercise on pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Self reported pain intensity .. Pain intensity was evaluated before and after exercise with 'Visual Analog Scale'. Each item scored is 0-10 (0=no pain 10=pain as bad as can be)	8 weeks
Range Of Motion	The CROM (Cervical Range-of-Motion Instrument) combines AMA-required inclinometers and magnets in an easy-to-use instrument. It eliminates positioning, zeroing and tracking errors that are common with stand-alone inclinometers. Standardized protocol minimizes the chance of examination error.	8 weeks
Kinesiofobia	Self reported. The Nottingham Health Profile (NHP) was originally created as a standardised tool to survey health problems and measure medical or social interventions. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life.	8 weeks
Disability	Self reported. The level of neck disability was evaluated before and after exercise with 'Neck Pain and Disability Score' . Each question is measured on a scale from 0 (no disability) to 5, and an overall score out of 100 is calculated by adding each item score together.	8 weeks
Quality of life level	Self reported. The Nottingham Health Profile (NHP) was originally created as a standardised tool to survey health problems and measure medical or social interventions. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life.	8 weeks
Pain pressure threshold	Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability.	8 weeks
Pain knowledge	Self reported. The Neurophysiology of Pain Questionnaire (NPQ) was devised to assess how an individual conceptualizes the biological mechanisms that underpin his or her pain. presents 12 items, and the answer options also consist of "true, false or undecided". Its psychometric properties constitute a one- -dimensional scale with good test-retest reliability. The results are interpreted as follows: each hit corresponds to one point, if the individual makes a mistake or choose the "undecided" alternati- ve, the item is reset to zero; therefore, the score ranges from zero to 12, and the higher the score, the greater the level of unders- tanding of the mechanisms present in pain	8 weeks

Collaborators and Investigators

• Sponsor: Istanbul Arel University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): June 6, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 16, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: ozdenyasarer neck pain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No