Neck pain is a frequent cause of discomfort and functional impairment, and can thus limit social activities and the ability to work [ 4 ]; in fact, NP causes health-related absence from work at levels comparable to low back pain [ 5 , 6 ], resulting in considerable healthcare costs [ 7 , 8 ].
Acute neck pain most commonly results from injury to the muscle, disk, nerve, ligament or facet joints with subsequent inflammation and spasm [ 9 , 10 ]. However, no data exist on the actual cause of common, uncomplicated neck pain [ 10 ].
In acute neck pain, damage to the neck structures as a result of injury, for example, releases biochemical mediators of inflammation such as prostaglandins [ 9 ], which stimulate the nociceptors and mediate pain and inflammation [ 11 ].
One of the goals of treating any acute pain syndrome should be inhibition or suppression of production of these inflammatory mediators, and a successful outcome is one that results in less inflammation and thus less pain [ 9 ].
Thus, any intervention should not only aim to aid the recovery from an acute episode usually within 4 weeks , but also to help prevent the development of long-term symptoms while minimizing the potential for adverse reactions to treatment [ 12 ].
Non-steroidal anti-inflammatory drugs NSAIDs are commonly used to reduce neck pain and inflammation [ 12 ]. However, to date only four trials have evaluated the efficacy and safety of oral NSAIDs as part of conservative management of acute NP [ 13 - 16 ], demonstrating unclear benefits [ 17 ]. Systematic review of the literature confirms that NSAIDs are effective analgesics and reduce inflammation in other musculoskeletal conditions [ 18 - 22 ].
Applied topically, diclofenac penetrates the skin barrier to reach joints, muscles and synovial fluid. It preferentially distributes and persists in the target inflamed tissues [ 23 ], achieving a sufficiently high concentration to exert local therapeutic activity [ 24 ]. Therefore, this randomized, double-blind, placebo-controlled study aimed to assess its efficacy and safety in the treatment of acute NP. The primary objective of the study was to assess the efficacy of DDEA 1.
Secondary objectives included the effect of DDEA 1. The clinical study ClinicalTrials. Informed consent was obtained from each subject in writing before randomization and the rights of subjects were protected. The study population consisted of male and female subjects, aged 18 years and over with acute NP originating from cervical joints and accompanying soft tissues.
Exclusion criteria included any neck pain that was attributable to an organic disease e. Novartis Pharmaceuticals Drug Supply Management produced the randomization list, using a system that automated the random assignment of treatment groups to randomization numbers.
At Visit 1 baseline , each subject underwent clinical evaluation and anamnesis, including previous and concomitant diseases, neck examination and diagnosis to ensure that neck pain could not be attributed to an organic disease. If all of the inclusion and none of the exclusion criteria were fulfilled, the subject was given the lowest available number on the randomization list by the investigator. Subjects, investigator staff, persons performing all assessments, monitors and data analysts remained blinded to the identity of the treatment from the time of randomization until database lock, using the following methods: 1 randomization data were kept strictly confidential until the time of unblinding and were not accessible by anyone involved in the study, 2 the identity of the treatments was concealed by the use of study drugs that were all identical in packaging, labeling, schedule of administration, appearance and odor.
Unblinding only occurred in the case of subject emergencies and at the conclusion of the study. Subjects applied the study medication for 5 days.
Efficacy was assessed at each visit. Additional examinations included measurement of vital signs blood pressure, pulse by the investigator on Days 1 and 5. Adverse events AEs were recorded at every visit. Subjects were randomized to topical treatment with DDEA 1. A dose of 2 g gel was applied topically with the fingertips on the affected area and massaged into the skin for around 1 min. The gel was applied 4 times a day for 5 days.
Rescue medication paracetamol, up to 2, mg daily was allowed during the study, except for 6 h prior to each study visit. Non-analgesic topical treatments could be applied to other parts of the body but no other concomitant therapies were allowed. POM was then defined as the average of the three scores. Pain-at-rest was measured at baseline and Days 2, 3 and 5 using a mm VAS 0, no pain to , extreme pain ; the subject stood in upright position for one minute relatively motionless and the extent of pain was recorded.
Functional impairment was evaluated at baseline and Days 2, 3 and 5, using the NDI [ 25 , 26 ] consisting of a series of questions each relating to an aspect of neck pain; the NDI score was the sum of scores for all answers given by the subject, ranging from 0 best outcome to 50 worst outcome.
The investigator was present at all assessments, but actively participated in the POM measurement only. The primary efficacy variable was POM after 48 h. Adverse events, their severity and relationship to study drug were recorded at every visit.
Vital signs blood pressure and pulse rate were assessed at the beginning and end of the study. With an observed SD of 18 mm, an observed difference of 8. Efficacy was analyzed in the intent-to-treat ITT population, which included all patients who received at least one dose of study drug. The safety population consisted of all subjects that received at least one dose of study drug.
Efficacy was tested with an ANCOVA model, with treatment and study site as main effects and the baseline value as a covariate. As a sensitivity analysis of the terms in the final model, the treatment by study site interaction was added to the model. The global assessment of treatment efficacy was tested with the Cochran-Mantel-Haenszel CMH test of mean ridits stratified by site. The percentages of subjects responding to treatment were compared with the CMH test of general association stratified by site.
Because little rescue medication was used, rescue medication consumption was summarized only as whether any rescue medication was taken, overall and by day to treat neck pain, with no statistical testing. There were no missing efficacy data. Hence, procedures to impute for missing data were not needed. In total, 72 subjects were randomized to treatment between April first subject in and July last subject out ; 36 to DDEA 1. All 72 patients completed the study and were included in the ITT population.
Stop using Voltaren Gel and let your healthcare provider know right away should any of these occur. Also cease use of the drug if lab tests show a high eosinophil count , which can lead to symptoms such as:. Be sure to read the drug label and package insert that comes with Voltaren Gel.
These will note the serious adverse reactions that can be caused by this drug. Long-term NSAID use can lead to serious kidney issues such as renal papillary necrosis, a condition in which parts of the kidney die. NSAIDs can also lead to severe and sometimes fatal skin conditions such as:. Long-term treatment with Voltaren can impact your liver enzymes. These may be higher than normal even before symptoms show up, and they can be a sign of serious liver issues that can be fatal or require a liver transplant.
Using these at the same time ups the total drug dose your body absorbs. This can amplify the risk of side effects. Don't apply Voltaren Gel to areas of your face or body that have makeup or sunscreen on them. The combined use of these has not been tested. Therefore, it is not known whether this is safe to do. Voltaren Gel is a topical pain aid prescribed by a healthcare provider to treat pain from OA in the knees, hands, and other joints. Voltaren Gel should not used in people at risk for heart attack or stroke or who have had recent heart surgery.
The drug should be used with caution in people in people with certain health issues such as kidney or liver disease. Do not use the gel at the same time as other NSAIDs or aspirin as this can raise the risk of adverse events.
These events can be serious and sometimes fatal. Also, do not apply Voltaren Gel to areas of the skin with makeup or other products on them. Their combined use has not been tested.
Voltaren Gel has expanded treatment options for OA. It doesn't matter if the drug is applied to your skin or taken in pill form. Protect your health by taking the drug as stated on the drug label or prescribed by your healthcare provider.
And be sure to stop taking the drug and let your healthcare provider know if side effects do occur. Learn tips for managing arthrits pain, medications, and daily challenges. Neck pain can be the result of stress, tension and poor posture and tends to affect us more as we age. Here we explore its causes and look at how to relieve neck pain. Relieve your pain. Stiffness or a knot in your neck can cause pain, which may spread to your shoulders, upper back or arms.
Neck pain may be associated with compression of the nerves in the neck, which can lead to numbness, weakness or a tingling sensation in your hand and arm. Neck pain can also be accompanied by feelings of muscle tightness and spasms and headache.
You may hear or feel clicking or grating when you move your head, caused by bones moving against each other or ligaments rubbing on the bone. Neck pain can become a real pain in the neck by preventing you from carrying out the most basic movements, such as turning your head to look around you or lifting up your shopping bags, without feeling discomfort.
If you wake up to find your neck twisted to one side and locked in that position, it could be acute torticollis or stiff neck.
This is often the result of spasm in your neck muscles. The causes may include bad posture or poor support when sleeping.
It usually only lasts hours, but can take a week to get better. Neck pain has many causes, from injuries, or the result of stress, tension or poor posture.
It is a very common problem, although we are more likely to suffer from neck aches and pains as we get older.
However, if your neck pain is accompanied by numbness, loss of strength in your arms or hands, or shooting pain into your shoulder or arm, it is recommended that you visit your doctor. You can ask your healthcare professional for suitable exercises such as stretches and gentle movements to recover strength and flexibility. Find out more. Get a better understanding of why our bodies experience the sensation of pain and the many causes of body pain.
Learn more about the benefits of exercise and how keeping fit can help you to stay healthy and relieve pain. WHO Physical activity. All rights reserved. Glaxo Smith Kline plc. Registered in England and Wales No. February Contactus-me gsk. Learn about neck pain Neck pain can be the result of stress, tension and poor posture and tends to affect us more as we age. Symptoms of neck pain Stiffness or a knot in your neck can cause pain, which may spread to your shoulders, upper back or arms.
Neck pain can also be accompanied by feelings of muscle tightness and spasms and headache.
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