Effectiveness Comparison of Thoracic Thrust Manipulation in People With Neck or Low Back Pain

NCT04981574 | Completed

• 1 other identifier: Alcalá
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To compare the effectiveness of thoracic thrust manipulation, together with massages techniques and stretching, between people with neck pain versus people with low back pain. Methods: The research will be performed from August 2021 to October 2021 at the University of Alcala de Henares. (Madrid) A minimum of forty-six (46) volunteers will participate in this research, and they will be divided in two groups of twenty-three (23). One group will be formed by candidates suffering from neck pain (group A) and the other one by candidate with low back pain (group B). Both groups will receive the same treatment and specific stretching exercises as applicable in accordance to the pain area, e.g.: group A will get the massage and the stretching exercises more suitable for the neck pain and group B the same but for the low back pain. Nevertheless both groups will receive the same technical thrust manipulation in thoracic area. All these treatments will be applied of the volunteers at the University of Alcalá. The treatment includes the following activities:

1. 1.Twenty (20) minutes massage in the pain area, as applicable.
2. 2.Technical thrust manipulation in thoracic area.
3. 3.Ten (10) minutes stretching in accordance to the pain area treated. The stretching shall be repeated twice a week by each volunteer.
4. 4.Before first session. (In this evaluation will be also analyzed demographic variables i.e.: height, weight, age, gender, academic level, smoker/no smoker)
5. 5.Between third and fourth session.
6. 6.After sixth session.
7. 7.Four weeks after sixth session.

Conditions

Neck Pain; Low Back Pain

Keywords

neck pain; low back pain; spinal manipulation; acute pain

Outcome Measures

Primary Outcomes (1)

• Change in Neck and Low Back Pain

  using a Visual Analogue Scale (VAS) from 0 to 10

  Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement

Secondary Outcomes (4)

• Change in Neck Pain related disability

  Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement

• Change in Health related quality of life (HRQoL)

  Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement

• Change in kinesiophobia

  Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement

• Change in Low Back Pain related disability

  Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement

Study Arms (2)

A group: neck pain

EXPERIMENTAL

Other: Massage and stretching on neck area and thoracic thrust manipulation

B group: low back pain

EXPERIMENTAL

Other: Massage and stretching on low back area and thoracic thrust manipulation

Interventions

Massage and stretching on neck area and thoracic thrust manipulation OTHER

1. Twenty (20) minutes massage in the neck area. The volunteer will be in prone position during the massage. 2. Technical thrust manipulation in thoracic area. For this technique the volunteer will be in supine position with their arms folded on the chest (making a "V"). The therapist will locate one hand on the spinous processes to be treated, and the other one on the arms of the patient to make easier the manipulation. 3. Ten (10) minutes specific stretching for the neck area. These stretching exercises shall be repeated twice a week by each volunteer. Stretching will be made on the trapezius superior, musculus levator scapulae and sternocleidomastoideus holding the position thirty (30) seconds. Each muscle stretch shall be repeated three times.

A group: neck pain

Massage and stretching on low back area and thoracic thrust manipulation OTHER

1. Twenty (20) minutes massage in the low back area. The volunteer will be in prone position during the massage. 2. Technical thrust manipulation in thoracic area. For this technique the volunteer will be in supine position with their arms folded on the chest (making a "V"). The therapist will locate one hand on the spinous processes to be treated, and the other one on the arms of the patient to make easier the manipulation. 3. Ten (10) minutes specific stretching for the low back area. These stretching exercises shall be repeated twice a week by each volunteer. Stretching activities will be: cat-cow pose, lower back stretches and knee twist holding the position thirty (30) seconds. Each muscle stretch shall be repeated three times.

B group: low back pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Non-specific neck/low back pain for the last three (3) months before the first session.

You may not qualify if:

• Previous surgery in the areas covered by this research (neck and/or low back)
• Red flags: Cancer or tumor, fracture...
• Scoliosis or osteoporosis
• Neck or low back pain with radiculopathy symptoms
• Central nervous system involvement
• Fear to manipulation
• Neck pain associated with whiplash injuries on the last six (6) months
• Pregnant women
• Not understand, write and speak Spanish fluently

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Alicia Masip

Alcalá de Henares, Madrid, 28801, Spain

Location

MeSH Terms

Conditions

Neck Pain; Low Back Pain; Acute Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Alexander Achalandabaso

  University of Jaén

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: It is a controlled clinical trial with parallel groups

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 29, 2021
• Study Start: August 4, 2021
• Primary Completion: September 29, 2021
• Study Completion: October 27, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

ES (1)