Clinical trial NCT05085600: Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain
Official title: Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain and Upper Cervical Spine Dysfunction. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Keywords: spine
manual therapy
exercise
chronic neck pain
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. 50% of the adult population will experience cervical pain at some point during the year.

The objective of this study is to compare the effectiveness of a single exercise session with manual therapy techniques of the upper cervical spine against a single exercise session in patients with chronic neck pain and upper cervical spine dysfunction.

The treatment will be applied by 1 therapist with orthopedic manual therapist (MT)-specialist training and more than 10 years of MT experience.

The primary outcome measurements will be cervical mobility and cervical pressure pain threshold. Intensity of pain will be also used as secondary outcome measure. These measurements shall be taken before and immediately after the relevant intervention.

Exercise Group After the baseline assessments, patients will performed the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine.

In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions.

The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will be mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side. Also, no pain will be allowed in the positions. Exercises were always carried out without pain, because pain can be an inhibitor of muscle contraction.

The Exercise (E) group will carried out one 20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks.

Manual Therapy + Exercise Group The MT + E group will carried out 20-minute sessions led by an experienced physical therapist. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation (high velocity low amplitude) and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise. The MT techniques were applied depending on the clinical findings in each patient.

Detailed description: Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. 50% of the adult population will experience cervical pain at some point during the year.

The objective of this study is to compare the effectiveness of a single exercise session with manual therapy techniques of the upper cervical spine against a single exercise session in patients with chronic neck pain and upper cervical spine dysfunction.

The treatment will be applied by 1 therapist with orthopedic manual therapist (MT)-specialist training and more than 10 years of MT experience.

The primary outcome measurements will be cervical mobility and cervical pressure pain threshold. Intensity of pain will be also used as secondary outcome measure. These measurements shall be taken before and immediately after the relevant intervention.

Exercise Group After the baseline assessments, patients will performed the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine.

In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions.

The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will be mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side. Also, no pain will be allowed in the positions. Exercises were always carried out without pain, because pain can be an inhibitor of muscle contraction.

The Exercise (E) group will carried out one 20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks.

Manual Therapy + Exercise Group The MT + E group will carried out 20-minute sessions led by an experienced physical therapist. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation (high velocity low amplitude) and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise. The MT techniques were applied depending on the clinical findings in each patient.

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with chronic neck pain
* More than 18 years old
* Loss of mobility in one or more upper cervical spine segments found through manual assessment according to Zito et al. (2006) and Kaltenborn (2012).
* A positive result in the Flexion rotation-test in the upper cervical spine (less than 32º or a difference of 10º or more between the two rotations.
* Not being able to exceed 24 mmHg in the cranio-cervical flexion test.
* Signing the informed consent.

Exclusion Criteria:

* Contraindication to manual therapy or exercise (pathological changes due to neoplasm, inflammation infections, osteopenia, congenital collagenous compromise syndromes "Down´s, Ehlers-Danlos, Grisel, Morquio"
* Marked degeneration of the cervical spine that may affect cervical spine ligament integrity.
* History of trauma to cervical vessels.
* Anticoagulant therapy or blood clotting disorders or to have participated in any program of exercises or manual therapy treatments designed to improve the performance of the cervical region in the previous 3 months.
* Post-traumatic neck pain or red flags according to Rushton et al.
* Inability to maintain the supine position, use of pacemakers, an inability to perform the flexion rotation-test
* Language difficulties that hinder understanding of informed consent or completion of the questionnaires necessary for this study.
* Subjects with litigation or lawsuits pending

Primary outcomes:
measure: Active range of motion mobility in the inferior cervical region (º)
timeFrame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
measure: Active range of motion mobility in the upper cervical region (º)
timeFrame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
measure: Pressure Pain Threshold (Kpa)
timeFrame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary outcomes:
measure: Pain Intensity (Visual analogue scale 0-100 mm)
timeFrame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References: