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NCT Number: NCT03328351

Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy

Background & Purpose: Cervical radiculopathy is a neurological disorder, which commonly results because of nerve compression. There are different types of physical therapy interventions that are used for cervical radiculopathy. The evidence of effectiveness of manual therapy in cervical radiculopathy is still limited. Short-term hypoalgesic effects after manual therapy was found in different musculoskeletal conditions. However, the effectiveness of manual therapy in patients with cervical radiculopathy hasn't been investigated yet. Therefore, the aim of study is to examine the short-term effect of manual therapy (mobilization) on the sensory features in patients with chronic cervical radiculopathy.

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Key information

Conditions

Cervical Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East jeddah general hospital, Jeddah, Saudi Arabia

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About this study

Participants:

The sample size was calculated using G*power 3.1(F test, analysis of variance [ANOVA]: repeated measure, within between interaction, and a priori: compute required sample size). A result of 10 participants (treatment group=5 and sham group=5) was used to calculate the effect size (ES) of 0.44 for the pressure pain threshold on the cervical spine after the intervention(immediate effect) between group. The power estimated for ANOVA for the two group with a significance of 0.05 revealed that a total sample size of 28 participants was necessary to obtain a power of 0.80. . a minimum of 14 needed to be recruited in this study Participants with unilateral neck pain and radiating symptoms to upper extremity of more than three months were recruited from King Abdul-Aziz Hospital and East Jeddah general hospital in Jeddah, Saudia Arabia All patients signed a consent form before they participate in the study after explaining all procedures to them. The study was approved by the Institutional Review Board (IRB) at the University of Dammam (IRB Number: PGS-20160-30-142) and was approved by ministry of health at Saudia Arabia (IRB number: H-02J-002). All electronic data pertinent to the patients were being saved in a secured laptop, whereas the paper document will be kept in a locked cabinet.

Data analysis:

All statistical analysis was performed using IBM SPSS version 20 (Armonk, NY: IBM Corp). Significance levels will be set at p ≤ 0.05. Mean and standard deviation will be calculated as descriptive statistics. One-way repeated measures analysis of variance (ANOVA) and post hoc comparison, if needed will calculate the differences in the outcome measures: Quantitive sensory testing (QST), pain intensity, and active CROM

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • unilateral neck pain and radiating to upper extremity > 3 months.
  • age :between 35 to 65 years old.
  • Presence 3 out of 4 positive findings:
  • spurling test.
  • distraction test,
  • upper limb neurodynamic test for median nerve
  • ipsilateral cervical rotation test less than 60 degrees.

Exclusion criteria

  • osteoporosis.
  • tumor.
  • metabolic disease (DM,resting blood pressure are greater than 140/90).
  • rheumatoid arthritis.
  • history of whiplash injury.
  • myelopathy.
  • pregnancy.
  • history of cervical or thoracic surgery
  • generalized neurological disorders .
  • leg surgery or disease (fracture) -

Treatment and study plan

Manual therapy

Other
  • Manual therapy: One of the following techniques was used for the treatment group based on the patients' response (i.e centralization and reduction of symptoms).
  • Cervical postero-anterior vertebral mobilization glides:

a central posteranterior (PA) or unilateral PA oscillatory pressure of grade III on the patient's most symptomatic level for 2 minute and 3 sets .

  • Cervical lateral vertebral glides :at grade III for 1 minute and 3 sets.
  • Strengthening Exercises:

for deep neck flexor muscles for 10 seconds and repeating it for 10 times.

Other names: mobilization, deep neck flexor exercise

Superficial soft tissue massage

Other
  • Superficial soft tissue massage: The researcher applied a superficial effleurage massage without moving the deeper tissue for 2 minutes for 3 sets

Strengthening Exercises:

for deep neck flexor muscles for 10 seconds and repeating it for 10 times

Other names: deep neck flexor exercise

Primary outcomes

  1. pressure pain threshold (PPT)

    Time frame: Change from baseline in PPT at immediate post intervention

    An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).

  2. pressure pain threshold (PPT)

    Time frame: Change from baseline in PPT at 3 weeks post intervention

    An electronic algometer (Somedic AB, Farsta, Sweden) was used to quantify pain intensity (K pascal).

Secondary outcomes

  1. Warmth/cold detection threshold and heat/cold pain threshold

    Time frame: Change from baseline in thermal detection & pain threshold at immediate post intervention

    A Thermotest System (SenseLab - Modular Sensory Analyser, Somedic AB, Horby, Sweden) was used to determine the thermal thresholds in degrees (°C )

  2. Warmth/cold detection threshold and heat/cold pain threshold

    Time frame: Change from baseline in thermal detection & pain threshold at 3 weeks post intervention

    A Thermotest System (SenseLab - Modular Sensory Analyser, Somedic AB, Horby, Sweden) was used to determine the thermal thresholds in degrees (°C )

  3. The Neck Disability Index (NDI)

    Time frame: Change from baseline in NDI at immediate post intervention

    The NDI is used to measure the patient reported disability in percentage

  4. The Neck Disability Index (NDI)

    Time frame: Change from baseline in NDI at 3 weeks post intervention

    The NDI is used to measure the patient reported disability in percentage

  5. Active Cervical Range of Motion

    Time frame: Change from baseline in CROM at immediate post intervention

    Cervical range of motion (CROM) device was used to assess the cervical range of motion in degree.

  6. Active Cervical Range of Motion

    Time frame: Change from baseline in CROM at 3 weeks post intervention

    Cervical range of motion (CROM) device was used to assess the cervical range of motion in degree.

  7. Numerical Pain Rating Scale (NPRS)

    Time frame: Change from baseline in NPRS at immediate post intervention

    The NPRS was used to assess a patient's level of pain in (11 points: 0 means no pain and 10 means severe pain.

  8. Numerical Pain Rating Scale (NPRS)

    Time frame: Change from baseline in NPRS at 3 weeks post intervention

    The NPRS was used to assess a patient's level of pain in (11 points: 0 means no pain and 10 means severe pain.

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

Short-term Effect of Manual Therapy on Sensory Features in Patients With Cervical Radiculopathy: A Randomized Triple-blind Experimental Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 1, 2017
Registry last updated
Nov 1, 2017

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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