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Cervical RadiculopathyNCT03328351

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

A study testing manual therapy and Superficial soft tissue massage in people with Cervical Radiculopathy, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Cervical Radiculopathy
What is being tested?
manual therapy and Superficial soft tissue massage
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
2 sitesSaudi Arabia
Study dates
18 Dec 2016to 24 Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • osteoporosis.
  • tumor.
  • metabolic disease (DM,resting blood pressure are greater than 140/90).
  • rheumatoid arthritis.
  • history of whiplash injury.
  • myelopathy.
Show all 10Show fewer
  • pregnancy.
  • history of cervical or thoracic surgery
  • generalized neurological disorders .
  • leg surgery or disease (fracture) -

Trial locations and contacts

2 sites in 1 country.

Saudi Arabia2 sites

  • East jeddah general hospital

    Jeddah

  • king Abdulaziz hospital

    Jeddah

Other trials in Saudi Arabia

About this study

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

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.

Read the detailed description

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

Being tested
manual therapy, Superficial soft tissue massage
Keywords
Manual therapy, cervical radiculopathy, pressure pain threshold, physiotherapy
Medical subject headings
Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • manual therapyOther

    Also called mobilization, deep neck flexor exercise

    1. 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).
    2. 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 .
    3. Cervical lateral vertebral glides :at grade III for 1 minute and 3 sets.
    4. Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times.

  • Superficial soft tissue massageOther

    Also called deep neck flexor exercise

    1. 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

Study groups in NCT03328351
Study groupRoleWhat they receive
manual groupExperimental1. The Manual therapy (Mobilization): 1. Cervical postero-anterior vertebral mobilization glides: the mobilization was grade 3 for 2 min 3 set 2. Cervical lateral vertebral glides: the mobilization was grade 3 for 1 min 3 set. 2. Strengthening Exercises for deep neck flexor muscle
Receives: Other: manual therapy
sham groupSham comparator1. Superficial soft tissue massage 2. Strengthening Exercises: for deep neck flexor muscles for 10 seconds and repeating it for 10 times .
Receives: Other: Superficial soft tissue massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pressure pain threshold (PPT)

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

    Measured: Change from baseline in PPT at immediate post intervention

  2. pressure pain threshold (PPT)

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

    Measured: Change from baseline in PPT at 3 weeks post intervention

Secondary outcomes (8)

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

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

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

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

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

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

  3. The Neck Disability Index (NDI)

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

    Measured: Change from baseline in NDI at immediate post intervention

  4. The Neck Disability Index (NDI)

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

    Measured: Change from baseline in NDI at 3 weeks post intervention

  5. Active Cervical Range of Motion

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

    Measured: Change from baseline in CROM at immediate post intervention

  6. Active Cervical Range of Motion

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

    Measured: Change from baseline in CROM at 3 weeks post intervention

  7. Numerical Pain Rating Scale (NPRS)

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

    Measured: Change from baseline in NPRS at immediate post intervention

  8. Numerical Pain Rating Scale (NPRS)

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

    Measured: Change from baseline in NPRS at 3 weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2017
  2. Study start18 Dec 2016
  3. Primary completion24 Aug 2017
  4. Study completion24 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
triple-blind (The researcher was blinded to the outcome measures, whereas the assessor, who performed the outcome measures was blinded to the patient groups. The patient was blinded to treatment)
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03328351
Sponsor's protocol ID
Dammam University
Status last verified
Oct 2017
First submitted
2 Oct 2017
Last updated
1 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alshami AM, Bamhair DA. Effect of manual therapy with exercise in patients with chronic cervical radiculopathy: a randomized clinical trial. Trials. 2021 Oct 18;22(1):716. doi: 10.1186/s13063-021-05690-y.

    PubMed 34663421

Questions about this trial

What is this clinical trial studying?

A study testing manual therapy and Superficial soft tissue massage in people with Cervical Radiculopathy, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pressure pain threshold (PPT) (time frame: Change from baseline in PPT at immediate post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03328351, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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