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Completed

NCT Number: NCT06803264

Effectiveness of Activity Oriented Therapy and Traditional Therapy in Cervical Discopathic Pain Syndrome

Title: Effectiveness of Activity Oriented Therapy and Traditional Therapy in Cervical Discopathic Pain Syndrome

Procedures: You will be asked to complete a form containing questions characterizing the study group and several questionnaires before starting treatment, such as: NDI, CESD-R, STAI and the NRS scale. A photo of the head and shoulder area will also be taken in a front and side standing position. After completing the two-week treatment, you will be asked again to complete questionnaires and pose for photos. You will be informed about a follow-up visit 3 months after the end of therapy, during which you will be asked for the last time to complete questionnaires and pose for a photo.

Benefits: There are no direct benefits to you other than participating in a therapy more commonly used for cervical pain syndromes and the opportunity to discuss your experience with neck pain with a specialist. The information we obtain will help scientists better understand the problem of treating neck pain.

Risk: There are no physical risks to you while conducting this research. All information obtained from you will be anonymous. Your name and image will not be used in this study or reports.

Confidentiality: All research records will be confidential and appropriately secured. Records will only be published with your consent or by court order or as required by law. Any publication resulting from this research will not use identifying information, such as your name or likeness.

Freedom to opt out: Participation in the study is completely voluntary and free of charge. You may withdraw from this study at any time without any consequences.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Clinic "Azory"

Krakow, Poland

About this study

The purpose of the study was to evaluate the effectiveness of the Activity Oriented Therapy (N.A.P. therapy) and traditional therapy during disc-related neck pain in terms of pain intensity, disability, Forward Head Posture (FHP), anxiety as a condition and level of depression. Patients were qualified based on a medical examination. Respondents were randomly divided into two groups.

The therapies were performed by experienced physiotherapists in cooperation with a psychologist. Treatment in both groups included 10 therapy sessions held daily from Monday to Friday over a two-week period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • qualifying: non-traumatic, disc-like, chronic (symptoms lasting more than 3 months) cervical pain of mechanical origin, localized in the cervical region with the possibility of radiation to the upper edge of the scapula and head (without root symptoms and neurological disorders), classified as syndrome No. 1 according to the Quebec Task Force (QTF) Classification, and a condition not requiring surgery.

Exclusion criteria

  • comorbid advanced neurological, rheumatic, urological, psychiatric diseases, and unsystematic participation in in therapy.

Treatment and study plan

Activity Oriented therapy (N.A.P.)

Other

The following six exercises were used, each of which was performed 10 times. Their progression was introduced by changing positions, individually adjusted to the patient's capabilities.

  • Eccentric infrahyoid muscle work during breathing activity and phonation of the "l"sound.
  • Reciprocal innervation of suboccipital muscles in gaze activity.
  • Stimulation of the diaphragm in the activity of breathing and phonation.
  • Repeated eccentric activity of the sternocleidomastoid (SCM) muscles during body transfer activity.
  • Repeated eccentric activity of scalene muscles in blanket pulling activity.
  • Eccentric work of suboccipital muscles in the activity of biting a snack.

traditional therapy

Other

Traditional therapy included:

  • Isometric work of the neck muscles.
  • Self-assisted active exercises for the shoulder girdle muscles.
  • Active exercises in relief for the muscles of the shoulder girdle performed in the sitting position in the transverse plane.
  • TENS current treatment performed in the cervical spine and shoulder girdle in the forward lying position.
  • The local cryotherapy treatment with carbon dioxide.

Primary outcomes

  1. The Numerical Rating Scale (NRS)

    Time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up

    The Numerical Rating Scale (NRS), which contains 11 levels of pain intensity, where 0 means no pain and 10 means maximum pain

  2. The Neck Disability Index (NDI)

    Time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up

    The Neck Disability Index (NDI) questionnaire, which examines the level of disability from NP. A patient can score between 0 and 50 points. A score between 1-4 points indicates no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability, and above 35 points total disability.

  3. The photographic method to assess Forward Head Posture (FHP)

    Time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up

    The photographic method to assess FHP. Based on photographs of the shoulder area and head taken in the forward and lateral standing positions, two angles were measured using the computer program GIMP (version 2.10.34). The camera was placed on a tripod at a distance of 150 cm from the patient. Cranio Vertebral Angle (CVA) was measured in the sagittal plane, while Frontal Head Tilt angle (FHT) was measured in the frontal plane. A higher score for CVA and a lower score for FHT indicate improvement in FHP. The reliability of the described procedure is rated as high. In the author's study, images were taken with a SONY DSC-W810B camera.

  4. The State-Trait Anxiety Inventory (STAI)

    Time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up

    The State-Trait Anxiety Inventory (STAI), which examines the level of anxiety understood as a transient and situationally conditioned state of the individual and anxiety as a relatively stable personality trait. The STAI consists of two subscales, but only the scale for measuring anxiety-state (X-1) was used in this study. Each subscale can be scored from 20 to 80. High values indicate higher levels of anxiety.

  5. The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)

    Time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up

    The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R). This is a self-report scale that examines levels of depression. It consists of 20 statements relating to mood and behavior observed over the past two weeks. The lowest score is 0 and the highest score is 80. The higher the scores, the higher the level of depression.

Sponsors and collaborators

Lead sponsor

University School of Physical Education, Krakow, Poland

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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